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Finding Medical Device and Drug Approval Information Through the Food and Drug Administration Databases

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Finding Medical Device and Drug Approval
July 23, 2024
Information Through the Food and Drug
Kate M. Costin
Administration Databases
Research Librarian

Information Through the Food and Drug Administration Databases Updated May 19, 2025 (R48133) Jump to Main Text of Report

Summary

The U.S. Food and Drug Administration (FDA) maintains a variety of publicly available The U.S. Food and Drug Administration (FDA) maintains a variety of publicly available
databases containing information vital to the agencydatabases containing information vital to the agency’'s regulatory oversight of the s regulatory oversight of the

medical device and pharmaceutical industries. The data compiled in these databases are medical device and pharmaceutical industries. The data compiled in these databases are
acquired through legal reporting requirements set forth by laws including the Federal Food, Drug, and Cosmetic acquired through legal reporting requirements set forth by laws including the Federal Food, Drug, and Cosmetic
Act (FFDCA) and the Public Health Service Act (PHSA). Additionally, data can be acquired by the agency Act (FFDCA) and the Public Health Service Act (PHSA). Additionally, data can be acquired by the agency
pursuant to various regulatory requirements for devices and drugs.pursuant to various regulatory requirements for devices and drugs.
Congressional Congressional staffoffices may consult the FDA may consult the FDA’'s catalog of databases to identify information on a medical device or s catalog of databases to identify information on a medical device or
drug’drug's current status in the United States. The data collected in these databases can be helpful in a variety of s current status in the United States. The data collected in these databases can be helpful in a variety of
efforts, including tracking compliance with current FDA regulations, determining the regulatory status of a efforts, including tracking compliance with current FDA regulations, determining the regulatory status of a
particular product, and monitoring notification of product shortage or recall.particular product, and monitoring notification of product shortage or recall.
Since there is not a There is no single, searchable platform on the FDA single, searchable platform on the FDA’'s website that allows users to search across the s website that allows users to search across the
agency’agency's entire catalog of databasess entire catalog of databases, this. This report provides information on several frequently consulted FDA report provides information on several frequently consulted FDA
medical device and drug databases. The report is intended to provide an overview of select databases to help users medical device and drug databases. The report is intended to provide an overview of select databases to help users
understand the types of information available; it is not a comprehensive listing of all current FDA databases. For understand the types of information available; it is not a comprehensive listing of all current FDA databases. For
each database included, CRS provides information on how to access the database, the types of data in the each database included, CRS provides information on how to access the database, the types of data in the
database, and each databasedatabase, and each database’'s currency. Data availability and accessibility will vary depending on the scope, types s currency. Data availability and accessibility will vary depending on the scope, types
of data, search capabilities, and terminology used by each individual database.of data, search capabilities, and terminology used by each individual database.
This report also provides an overview of the FDA centers responsible for regulating medical device and drug This report also provides an overview of the FDA centers responsible for regulating medical device and drug
products, brief summaries of the FDAproducts, brief summaries of the FDA’'s approval processes for medical devices and drugs, references to additional s approval processes for medical devices and drugs, references to additional
CRS products on the FDACRS products on the FDA’'s regulation of these products, and a glossary of terms. In March 2025, the Secretary of Health and Human Services announced restructuring that includes FDA. At this report's publication, the potential effects of restructuring on activities within FDA are unknown. This report discusses FDA databases as they were prior to the restructuring announcement.

Purpose and Scope

s regulation of these products, and a glossary of terms.




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Contents
Purpose and Scope ........................................................................................................................... 1
FDA Regulation of Drugs and Medical Devices ............................................................................. 2
Medical Devices Databases ............................................................................................................. 4
Drugs and Biologics Databases ....................................................................................................... 9
Additional CRS Resources ............................................................................................................ 13

Tables
Table 1. Databases Maintained by FDA Centers ............................................................................. 3
Table 2. Medical Devices Databases ............................................................................................... 6
Table 3. Drugs and Biologics Databases ........................................................................................ 11

Appendixes
Appendix. Glossary ....................................................................................................................... 14

Contacts
Author Information ........................................................................................................................ 15


Congressional Research Service
Finding Medical Device and Drug Approval Information Through the FDA Databases

Purpose and Scope
The U.S. Food and Drug Administration (FDA) maintains a variety of publicly available The U.S. Food and Drug Administration (FDA) maintains a variety of publicly available
databases containing information vital to the agencydatabases containing information vital to the agency’'s regulatory oversight of the medical device s regulatory oversight of the medical device
and pharmaceutical industries. The data compiled in these databases are acquired by the FDA and pharmaceutical industries. The data compiled in these databases are acquired by the FDA
through legal reporting requirements set forth by laws including the Federal Food, Drug, and through legal reporting requirements set forth by laws including the Federal Food, Drug, and
Cosmetic Act (FFDCA) and the Public Health Service Act (PHSA). Additionally, data may be Cosmetic Act (FFDCA) and the Public Health Service Act (PHSA). Additionally, data may be
acquired by the FDA pursuant to various regulatory requirements for devices and drugs.acquired by the FDA pursuant to various regulatory requirements for devices and drugs.1
1 These databases allow public users from sectors including industry, government, public These databases allow public users from sectors including industry, government, public
stakeholders, and academia to freely access data collected and maintained by the agency. The stakeholders, and academia to freely access data collected and maintained by the agency. The
variety of data maintained in the FDA databases is broad, from the current status of product variety of data maintained in the FDA databases is broad, from the current status of product
availability in the United States to the number of recorded adverse reactions reported to the availability in the United States to the number of recorded adverse reactions reported to the
agency.agency.
Congressional Congressional staffoffices may need to consult the FDA may need to consult the FDA’'s collection of databases in order to identify s collection of databases in order to identify
information related to medical products, includinginformation related to medical products, including
• current product availability (e.g., in shortage),current product availability (e.g., in shortage),
• current FDA device and drug marketing status,current FDA device and drug marketing status,2
• 2 current FDA device classification,current FDA device classification,
• adverse event(s) reporting, andadverse event(s) reporting, and
• manufacturer (including contact information).manufacturer (including contact information).
There is There is not ano single, searchable platform on the FDA single, searchable platform on the FDA’'s website that allows users to search across s website that allows users to search across
the agencythe agency’'s entire catalog of databases. The databases often contain both unique and overlapping s entire catalog of databases. The databases often contain both unique and overlapping
information. Users may need to use multiple databases depending on the information needed. information. Users may need to use multiple databases depending on the information needed.
Relevant data are also presented in a variety of formats on the FDARelevant data are also presented in a variety of formats on the FDA’'s website. For example, some s website. For example, some
data are accessible through interactive tables (e.g., data are accessible through interactive tables (e.g., Drug Recalls),), while other data are housed in while other data are housed in
standalone databases on the website https://www.accessdata.fda.gov/.standalone databases on the website https://www.accessdata.fda.gov/. For the purpose of this For the purpose of this
report, all data repositories on the FDAreport, all data repositories on the FDA’'s website will be referred to as a s website will be referred to as a database..
This report provides examples and is not a comprehensive listing of all FDA databases. The dataThis report provides examples and is not a comprehensive listing of all FDA databases. The data’s
's availability and accessibility will vary depending on the scope, types of data, search capabilities, availability and accessibility will vary depending on the scope, types of data, search capabilities,
and terminology used in the individual database. The report includes a direct link to each and terminology used in the individual database. The report includes a direct link to each
database, the types of data maintained in the database, and the databasedatabase, the types of data maintained in the database, and the database’'s frequency of update. s frequency of update.
The information provided for each database is not exhaustive and is meant only to illustrate its The information provided for each database is not exhaustive and is meant only to illustrate its
available content.available content.
Finally, while While the phrases the phrases premarketpremarket and and postmarket data are used throughout this report, are used throughout this report, it is
important to note that, in general, data for products currently undergoing FDA review are not in general, data for products currently undergoing FDA review are not
available publicly through the FDAavailable publicly through the FDA’'s website.s website.33 The information used to populate these databases The information used to populate these databases
is obtained through premarket submissions publicly released after FDA marketing authorization is is obtained through premarket submissions publicly released after FDA marketing authorization is
granted (where applicable; many medical devices are not subject to premarket review granted (where applicable; many medical devices are not subject to premarket review

1 Regulations promulgated pursuant to these statutory requirements are generally found in the Code of Federal
Regulations (C.F.R.), Title 21—Food and Drugs.
2 Marketing status indicates how a product is sold in the United States (e.g., prescription, over-the-counter).
3 FDA is restricted by regulation as to what it may publicly disclose with respect to commercial confidential
information (CCI). See 21 C.F.R. §807.95.
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requirements). To obtain data for products currently under FDA review, CRS recommends
contactingrequirements). To obtain data for products currently under FDA review, congressional offices may contact the FDA congressional liaison. the FDA congressional liaison.4
4 For definitions of terms used throughout this report, see For definitions of terms used throughout this report, see the Appendix.
the Appendix. FDA Regulation of Drugs and Medical Devices
The FDA, within the Department of Health and Human Services (HHS), is the federal agency The FDA, within the Department of Health and Human Services (HHS), is the federal agency
responsible for the safety, efficacy, and security of medical products, including human drugs, responsible for the safety, efficacy, and security of medical products, including human drugs,
biological products, medical devices, and radiation emitting products in the United States.biological products, medical devices, and radiation emitting products in the United States.55 Under Under
most circumstances, drugs, devices, and biologics may be marketed in the United States only if most circumstances, drugs, devices, and biologics may be marketed in the United States only if
they have been approved, cleared, or licensed by FDA.they have been approved, cleared, or licensed by FDA.66 In the premarket approval phase, the In the premarket approval phase, the
FDA reviews manufacturersFDA reviews manufacturers’' applications to market drugs or devices in the United States. Once applications to market drugs or devices in the United States. Once
the product is on the market, FDA continues its oversight of safety and effectiveness. The the product is on the market, FDA continues its oversight of safety and effectiveness. The
postmarket approval phase lasts as long as the item is in the market.postmarket approval phase lasts as long as the item is in the market.7 7
In general, drugs and devices are approved or cleared under the FFDCA,In general, drugs and devices are approved or cleared under the FFDCA,88 whereas biologics are whereas biologics are
licensed under the PHSA.licensed under the PHSA.99 For further information related to the FDA For further information related to the FDA’'s approval and regulation s approval and regulation
processes of drugs and medical devices, see CRS Report R41983, processes of drugs and medical devices, see CRS Report R41983, How FDA Approves Drugs and
Regulates Their Safety and Effectiveness, and CRS Report R47374, , and CRS Report R47374, FDA Regulation of Medical
Devices. In addition, the CRS In Focus IF11083, . In addition, the CRS In Focus IF11083, Medical Product Regulation: Drugs, Biologics,
and Devices, broadly summarizes selected differences in statutory requirements among drugs, , broadly summarizes selected differences in statutory requirements among drugs,
biologics, and devices.biologics, and devices.
The FDA consists of nine center-level organizations and 13 headquarter (HQ) offices.The FDA consists of nine center-level organizations and 13 headquarter (HQ) offices.1010 Within Within
the FDA, the following centers oversee drugs, biologics, and devices:the FDA, the following centers oversee drugs, biologics, and devices:
• Center for Biologics Evaluation and Research (CBER) oversees certain biologics Center for Biologics Evaluation and Research (CBER) oversees certain biologics
(e.g., vaccines and gene therapies).(e.g., vaccines and gene therapies).
• Center for Drug Evaluation and Research (CDER) oversees chemical drugs and Center for Drug Evaluation and Research (CDER) oversees chemical drugs and
some therapeutic biologics.11

4 CRS Report 98-446, Congressional Liaison Offices of Selected Federal Agencies, by Audrey Celeste Crane-Hirsch.
5 FDA, What We Do, https://www.fda.gov/about-fda/what-we-do.
6 Within the Code of Federal Regulations, see for drugs, 21 C.F.R. §314; for devices, see 21 C.F.R. Part 807, Subpart E
(510(k) clearance); 21 C.F.R. Part 814 (Premarket Approval); 21 C.F.R. Part 860, Subpart D (De Novo Request for
Classification). Biological products are licensed under Section 351 of the PHSA; some therapeutic protein products are
approved under Section 505 of the FFDCA.
7 CRS Report R41983, How FDA Approves Drugs and Regulates Their Safety and Effectiveness, by Hassan Z. Sheikh.
8 CRS In Focus IF11083, Medical Product Regulation: Drugs, Biologics, and Devices, by Amanda K. Sarata and
Hassan Z. Sheikh.
9 Certain biological products, such as hormonal products, are regulated under FFDCA For more information, see FDA,
Frequently Asked Questions About Therapeutic Biological Products, https://www.fda.gov/drugs/therapeutic-biologics-
applications-bla/frequently-asked-questions-about-therapeutic-biological-products.
10 FDA, FDA Organizations Chart, https://www.fda.gov/about-fda/fda-organization/fda-organization-charts.
11 For more information on the categories of therapeutic biological products regulated by CDER (under the FFDCA
and/or the PHSA, as appropriate), see FDA, Frequently Asked Questions About Therapeutic Biological Products,
https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/frequently-asked-questions-about-therapeutic-
biological-products.
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• some therapeutic biologics.11 Center for Devices and Radiological Health (CDRH) oversees medical devices Center for Devices and Radiological Health (CDRH) oversees medical devices
and radiologic products.and radiologic products.12
12 These centers are responsible for maintaining the publicly available databases on the FDAThese centers are responsible for maintaining the publicly available databases on the FDA’s
's website corresponding with their industries of oversight.website corresponding with their industries of oversight. Table 1 lists the databases included in lists the databases included in
this report, with the center(s) responsible for each databasethis report, with the center(s) responsible for each database’'s maintenance. Given that some s maintenance. Given that some
centers may have overlapping authority over certain medical products (e.g., combination centers may have overlapping authority over certain medical products (e.g., combination
products-therapeutic or diagnostic products that combine drugs, biologics, and devices),products-therapeutic or diagnostic products that combine drugs, biologics, and devices),1313 some some
databases appear in multiple columns.databases appear in multiple columns.

In March 2025, the Secretary of Health and Human Services announced restructuring that includes FDA. At this report's publication, the potential effects of restructuring on activities within FDA are unknown. This report discusses FDA databases as they were prior to the restructuring announcement.14

 Table 1. Databases Maintained by FDA Centers
The following table provides a list of select FDA databases organized by the FDA centers responsible for The following table provides a list of select FDA databases organized by the FDA centers responsible for
maintaining these databases.maintaining these databases.
CBER
CDER
CDRH
•
Database of Licensed Biological •
Drugs@FDA
•
Establishment Registration &
Products (Purple Book)a
•
Listing

Approved Drug Products with
•
Device Classification Under
Therapeutic Equivalence
•
Devices@FDA
Section 513(f)(2) (De Novo)b
Evaluations (Orange Book)
•
Product Classification
•
FDA Adverse Event Reporting
•
Database of Licensed Biological
Database
System (FAERS) public
Products (Purple Book)a
•
Device Classification Under
dashboardc
•
Approved Risk Evaluation and
Section 513(f)(2) (De Novo)b
•
CBER-Regulated Products
Mitigation Strategies (REMS)
•
Premarket Approvals (PMA)
Shortages
•
Postmarket Requirements and
•
•

510(k) Premarket Notification

Drug Recallsc
Commitments databasec
•
•

Over the Counter (OTC)

Postmarket Requirements and
•
Drug Establishments Current
Database
Commitments databasec
Registration Site
•
CLIA - Clinical Laboratory
•
FDA Adverse Event Reporting
Improvement Amendments
System (FAERS) public
dashboardc
•

CBER

CDER

CDRH

Database of Licensed Biological Products (Purple Book)a Device Classification Under Section 513(f)(2) (De Novo)b FDA Adverse Event Reporting System (FAERS) public dashboardc
  • CBER-Regulated Products Shortages
    • Drug Recallsc Postmarket Requirements and Commitments databasec
  • Drugs@FDA
  • Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)
    • Database of Licensed Biological Products (Purple Book)a
  • Approved Risk Evaluation and Mitigation Strategies (REMS)
    • Postmarket Requirements and Commitments databasec
  • Drug Establishments Current Registration Site
    • FDA Adverse Event Reporting System (FAERS) public dashboardc
  • FDA Drug Shortages
    • Drug Recallsc
  • Establishment Registration & Listing
  • Devices@FDA
  • Product Classification Database
    • Device Classification Under Section 513(f)(2) (De Novo)b
  • Premarket Approvals (PMA)
  • 510(k) Premarket Notification
  • Over the Counter (OTC) Database
  • CLIA - Clinical Laboratory Improvement Amendments
    • MAUDE (Manufacturer and MAUDE (Manufacturer and
    User Facility Device User Facility Device
    •
    FDA Drug Shortages
    Experience)Experience)
    •
    Drug Recallsc
    •
    Post-Approval Studies (PAS) Post-Approval Studies (PAS)
    Database
    •
    Database Total Product Life Cycle Total Product Life Cycle
    (TPLC)(TPLC)
    Source: Compiled by CRS based on information from FDA.gov.Compiled by CRS based on information from FDA.gov.
    a. a. Contains information about all FDA-licensed biological products regulated by CDER and information on all Contains information about all FDA-licensed biological products regulated by CDER and information on all
    FDA-licensed allergenic, cellular and gene therapy, hematologic, and vaccine products regulated by CBER.FDA-licensed allergenic, cellular and gene therapy, hematologic, and vaccine products regulated by CBER.
    b. b. Allows user to narrow search by FDA Center (e.g., CBER or CDRH).Allows user to narrow search by FDA Center (e.g., CBER or CDRH).
    c. c. Contain data from both CBER and CDER. Medical Devices Databases Contain data from both CBER and CDER.

    12 CRS In Focus IF11083, Medical Product Regulation: Drugs, Biologics, and Devices, by Amanda K. Sarata and
    Hassan Z. Sheikh.
    13 CRS Report R47374, FDA Regulation of Medical Devices, by Amanda K. Sarata.
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    Medical Devices Databases
    The CDRH regulates firms that manufacture, repackage, relabel, and/or import medical devices The CDRH regulates firms that manufacture, repackage, relabel, and/or import medical devices
    sold in the United States.sold in the United States.1415 Additionally, CDRH regulates radiation-emitting electronic products Additionally, CDRH regulates radiation-emitting electronic products
    (medical and nonmedical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens, (medical and nonmedical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens,
    and color televisions. Medical devices are regulated based on the risk posed to the consumer and and color televisions. Medical devices are regulated based on the risk posed to the consumer and
    are classified into the following categories.are classified into the following categories.
    • Class I medical devices are considered low risk. As such, general controls are Class I medical devices are considered low risk. As such, general controls are
    considered sufficient to provide reasonable assurance of safety and considered sufficient to provide reasonable assurance of safety and
    effectiveness.effectiveness.15
    • 16 Class II medical devices are considered moderate risk; therefore, general and Class II medical devices are considered moderate risk; therefore, general and
    special controls are considered to provide reasonable assurance of safety and special controls are considered to provide reasonable assurance of safety and
    effectiveness.effectiveness.16
    • 17 Class III medical devices are considered high risk; therefore, they are subject to Class III medical devices are considered high risk; therefore, they are subject to
    general controls and the PMA process to provide reasonable assurance of safety general controls and the PMA process to provide reasonable assurance of safety
    and effectiveness.and effectiveness.17
    18Unless specifically excluded by regulation, all devices must meet general controls. These include Unless specifically excluded by regulation, all devices must meet general controls. These include
    both premarket and postmarket requirements. General controls include 510(k) premarket both premarket and postmarket requirements. General controls include 510(k) premarket
    notification,notification,1819 registration, listing, and compliance with current good manufacturing practices as registration, listing, and compliance with current good manufacturing practices as
    set forth in FDAset forth in FDA’'s quality system regulations.s quality system regulations.1920 CRS Report R47374, CRS Report R47374, FDA Regulation of Medical
    Devices    , provides further information on the FDA device classification processes and device , provides further information on the FDA device classification processes and device
    regulatory controls.regulatory controls.
    Once a device is approved, the FDA has the authority to require product sponsors to perform a Once a device is approved, the FDA has the authority to require product sponsors to perform a
    post-approval study (or studies). These can occur at various stages, including the time of a post-approval study (or studies). These can occur at various stages, including the time of a
    premarket approval (PMA), humanitarian device exemption (HDE), or product development premarket approval (PMA), humanitarian device exemption (HDE), or product development
    protocol (PDP) application. Post-approval studies can provide patients, health care professionals, protocol (PDP) application. Post-approval studies can provide patients, health care professionals,
    the device industry, the FDA, and other stakeholders information on the continued safety and the device industry, the FDA, and other stakeholders information on the continued safety and
    effectiveness (or continued probable benefit, in the case of an HDE) of approved medical effectiveness (or continued probable benefit, in the case of an HDE) of approved medical
    devices.devices.20
    21 FDA databases include information associated with a specific medical device, such as the name FDA databases include information associated with a specific medical device, such as the name
    of a productof a product’'s manufacturer, the devices manufacturer, the device’'s current FDA classification, when the item was s current FDA classification, when the item was
    authorized for marketing by the FDA, or if adverse events with a device have been reported to the authorized for marketing by the FDA, or if adverse events with a device have been reported to the
    FDA.FDA.
    Table 2 provides select information for several FDA databases containing medical device data. provides select information for several FDA databases containing medical device data.
    For each entry, the table lists the circumstance in which a user might consult that database. For each entry, the table lists the circumstance in which a user might consult that database.
    Because terminology used by the FDA across the databases is not consistent, the table defines Because terminology used by the FDA across the databases is not consistent, the table defines
    what types of data each column encompasses.

    14 CRS Report R47374, FDA Regulation of Medical Devices, by Amanda K. Sarata.
    15 FFDCA §513(a)(1)(A); 21 U.S.C. §360c(a)(1)(A).
    16 FFDCA §513(a)(1)(B); 21 U.S.C. §360c(a)(1)(B).
    17 FFDCA §513(a)(1)(C); 21 U.S.C. §360c(a)(1)(C).
    18 21 C.F.R. §807.92.
    19 CRS In Focus IF11083, Medical Product Regulation: Drugs, Biologics, and Devices, by Amanda K. Sarata and
    Hassan Z. Sheikh.
    20 FDA, Post-Approval Studies (PAS) Database, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/
    pma_pas.cfm.
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    • what types of data each column encompasses. Proprietary Name: Name of device on record with the FDA. May also be listed Name of device on record with the FDA. May also be listed
    as as Device Name in select databases.in select databases.
    • Decision Date: Date of approval on record with the FDA. May be referred to as Date of approval on record with the FDA. May be referred to as
    Approval Date in select databases. in select databases.
    • Contact: This information may be recorded as the : This information may be recorded as the Applicant, Correspondent,
    Owner/Operator, or or Manufacturer on file with the FDA.on file with the FDA.
    • Class: Medical device classification assigned by the FDA. Device may be Medical device classification assigned by the FDA. Device may be
    considered considered Class I, Class II, or , or Class III..
    • 510(k) NumberNumber: A 510(k) is a premarketing submission made to FDA to A 510(k) is a premarketing submission made to FDA to
    demonstrate that the device to be marketed is as safe and effective, or is demonstrate that the device to be marketed is as safe and effective, or is
    substantially equivalent (SE), to a legally marketed device that is not subject to substantially equivalent (SE), to a legally marketed device that is not subject to
    premarket approval (PMA).premarket approval (PMA).21
    • 22 Regulation Number: A deviceA device’'s regulation number in the s regulation number in the Code of Federal
    Regulations. If the database does not reference a regulation number, the device . If the database does not reference a regulation number, the device
    has not yet been classified and the device class listed (1, 2, or 3) is proposed, not has not yet been classified and the device class listed (1, 2, or 3) is proposed, not
    final.


    21 21 C.F.R. §807.92; FDA, Device Approvals and Clearances, https://www.fda.gov/medical-devices/products-and-
    medical-procedures/device-approvals-and-clearances.
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    final. Table 2. Medical Devices Databases
    (“+” ("+" indicates that types of data are included in database; indicates that types of data are included in database; “—”"—" indicates that types of data are not included in database. indicates that types of data are not included in database.
    Click on each database to navigate to the site.)Click on each database to navigate to the site.)

    Data
    DatabaseaExample of database content
    Databasea
    Example of database content
    Proprietary
    and when to consult.
    Name
    Decision Date
    Contact
    Class
    510(k) Number
    Regulation Number
    Updated
    Establishment
    +
    —
    +
    +
    +c
    +
    Weekly
    Registration and Listingb

    Proprietary Name

    Decision Date

    Contact

    Class

    510(k) Number

    Regulation Number

    Updated

    Establishment Registration and Listingb     What company manufactures
    this device?
    Which Which devices are made by this
    manufacturer?
    Devices@FDA
    +
    +
    +
    —
    +
    +
    Weekly

    +

    —

    +

    +

    +c

    +

    Weekly

    Devices@FDA

     Is this device FDA approved or cleared?

    +

    +

    +

    —

    +

    +

    Weekly

    Product Classification Database

    What is this device'     or
    cleared?
    Product Classification
    —
    —
    —
    +
    —d
    +
    Weekly
    Database
    What is this device’s FDA
    classification?
    510(k) Premarket
    +
    +
    +
    —
    +
    +
    Weekly
    Notification
    s FDA classification?

    —

    —

    —

    +

    —d

    +

    Weekly

    510(k) Premarket Notification

    Is this device cleared?

    +

    +

    +

    —

    +

    +

    Weekly

    Device Classification     ?
    Device Classification
    +
    +
    +
    —
    —
    +
    Weekly
    Under Section 513(f)(2)
    (De Novo)e
    )e Does this device have a De
    Novo number?
    Premarket Approval
    +
    +
    +
    —
    —
    —
    Weekly
    (PMA)

    +

    +

    +

    —

    —

    +

    Weekly

    Premarket Approval (PMA)

    When was this Class III device approved?

    +

    +

    +

    —

    —

    —

    Weekly

    Over the Counter (OTC) Database

    Who manufacturers this OTC test?

    +

    +

    +

    —

    +

    +

    Weekly

    Clinical Laboratory Improvement Amendments (CLIA)f     Class III device
    approved?
    CRS-6
    link to page 10 link to page 11 link to page 11 link to page 11

    Data

    Databasea
    Example of database content
    Proprietary
    and when to consult.
    Name
    Decision Date
    Contact
    Class
    510(k) Number
    Regulation Number
    Updated
    Over the Counter (OTC)
    +
    +
    +
    —
    +
    +
    Weekly
    Database
    Who manufacturers this OTC
    test?
    Clinical Laboratory
    +
    +
    +
    —
    +
    +
    Weekly
    Improvement
    Amendments (CLIA)    f
    What is the CLIA categorization
    for the test system?
    ? What analyte does the test
    system detect?
    Manufacturer and User
    +
    —
    —g
    —
    —
    —
    Weekly

    +

    +

    +

    —

    +

    +

    • Weekly
    Manufacturer and User     Facility Device
    Experience (MAUDE)
    Are there adverse eventsevents
    reported for this device?
    Post-Approval Studies
    +
    +
    +
    —
    —
    —
    Weekly
    (PAS) Database
    Were there PAS required for
    this device?
    Total Product Life Cycle
    +
    —
    —h
    +
    —
    +
    Weekly
    (TPLC)

    +

    —

    —g

    —

    —

    —

    Weekly

    Post-Approval Studies (PAS) Database

    Were there PAS required for this device?

    +

    +

    +

    —

    —

    —

    Weekly

    Total Product Life Cycle (TPLC)

    Are there any postmarket FDA
    actions associated with this
    device?

    +

    —

    —h

    +

    —

    +

    Weekly

     Source: Compiled by CRS based on information from FDA.gov.Compiled by CRS based on information from FDA.gov.
    a. a. Database name in bold.Database name in bold.
    b. b. Registration and Listing does not denote approval or clearance of a firm or their device(s) by the FDA.Registration and Listing does not denote approval or clearance of a firm or their device(s) by the FDA.
    c. c. Premarket Submission Number (if available).Premarket Submission Number (if available).
    CRS-7

    d. d. Submission Type will note 510(k) submission, if applicable. will note 510(k) submission, if applicable.
    e. e. De Novo Classification is an alternate pathway to reclassify new medical devices automatically placed in class III after receiving a Not Substantially Equivalent (NSE) De Novo Classification is an alternate pathway to reclassify new medical devices automatically placed in class III after receiving a Not Substantially Equivalent (NSE)
    determination in response to a 510(k) submission (21 C.F.R. §860.200). Amended by Section 607 of the Food and Drug Administration Safety and Innovation Act determination in response to a 510(k) submission (21 C.F.R. §860.200). Amended by Section 607 of the Food and Drug Administration Safety and Innovation Act
    (FDASIA), to provide a second pathway allowing a sponsor to submit a de novo classification request to the FDA without first being required to submit a 510(k).(FDASIA), to provide a second pathway allowing a sponsor to submit a de novo classification request to the FDA without first being required to submit a 510(k).
    f. f.
    The Clinical Laboratory Improvement Amendments (CLIA) of 1988 (42 U.S.C. §263a; PHSA §353) and the associated regulations (42 C.F.R. §493) provide the The Clinical Laboratory Improvement Amendments (CLIA) of 1988 (42 U.S.C. §263a; PHSA §353) and the associated regulations (42 C.F.R. §493) provide the
    authority for certification and oversight of clinical laboratories and laboratory testing.authority for certification and oversight of clinical laboratories and laboratory testing.
    g. g. Manufacturer name is listed but does not include contact information in the entry.Manufacturer name is listed but does not include contact information in the entry.
    h. h. Manufacturer name may be listed but does not include contact information in the entry.Manufacturer name may be listed but does not include contact information in the entry.

    CRS-8
    link to page 14 link to page 14 link to page 6 Finding Medical Device and Drug Approval Information Through the FDA Databases

    Drugs and Biologics Databases
    To market a new prescription brand-name or generic drug for use in humans in the United States, To market a new prescription brand-name or generic drug for use in humans in the United States,
    the sponsor (generally the drug manufacturer) must submit a new drug application (NDA) to the the sponsor (generally the drug manufacturer) must submit a new drug application (NDA) to the
    FDA, demonstrating that the drug is safe and effective for its proposed use. Drugs are approved FDA, demonstrating that the drug is safe and effective for its proposed use. Drugs are approved
    via an NDA under Section 505 of the FFDCA, and biologics are licensed via a biologics license via an NDA under Section 505 of the FFDCA, and biologics are licensed via a biologics license
    application (BLA) under Section 351 of the PHSA. For generic drug products, the manufacturer application (BLA) under Section 351 of the PHSA. For generic drug products, the manufacturer
    can submit to FDA an abbreviated NDA (ANDA) demonstrating that the generic product is the can submit to FDA an abbreviated NDA (ANDA) demonstrating that the generic product is the
    same as the brand-name drug.same as the brand-name drug.22
    23 For NDAs, once the required materials are submitted by the sponsor, they are reviewed by CDER For NDAs, once the required materials are submitted by the sponsor, they are reviewed by CDER
    physicians, statisticians, chemists, pharmacologists, and other scientists. This group also reviews physicians, statisticians, chemists, pharmacologists, and other scientists. This group also reviews
    the sponsorthe sponsor’'s proposed labeling.s proposed labeling.23
    24 In general, the requirements and review pathway for BLAs are similar to the requirements and In general, the requirements and review pathway for BLAs are similar to the requirements and
    review pathway for NDAs. The product sponsor must demonstrate that the biologic and the review pathway for NDAs. The product sponsor must demonstrate that the biologic and the
    facilities and processes for manufacturing the product are safe, pure, and potent (i.e., effective). facilities and processes for manufacturing the product are safe, pure, and potent (i.e., effective).
    Biologics are subject to certain FFDCA provisions (e.g., Risk Evaluation and Mitigation Biologics are subject to certain FFDCA provisions (e.g., Risk Evaluation and Mitigation
    Strategies).Strategies).24
    25 For both drugs and biologics, manufacturers must report all serious and unexpected adverse For both drugs and biologics, manufacturers must report all serious and unexpected adverse
    events to FDA within 15 days of becoming aware of them.events to FDA within 15 days of becoming aware of them.2526 Clinicians and patients may report Clinicians and patients may report
    adverse events to the agency at any time. Once a drug is on the market, FDA can require the adverse events to the agency at any time. Once a drug is on the market, FDA can require the
    manufacturer to conduct additional studies or clinical trials based on newly acquired information, manufacturer to conduct additional studies or clinical trials based on newly acquired information,
    and can require labeling changes based on information it gathers from mandatory and voluntary and can require labeling changes based on information it gathers from mandatory and voluntary
    adverse event reports.adverse event reports.26
    27 Table 3 provides select information for several FDA databases containing drug data maintained provides select information for several FDA databases containing drug data maintained
    by CBER and CDER.by CBER and CDER.2728 For each entry For each entry, Table 3 lists the circumstance in which a user might lists the circumstance in which a user might
    consult that database. Because terminology used by the FDA across the databases is not consult that database. Because terminology used by the FDA across the databases is not
    consistent, below CRS defines what types of data each column encompasses.consistent, below CRS defines what types of data each column encompasses.
    • Proprietary Name: Name on record with the FDA. May also listed as Name on record with the FDA. May also listed as Trade
    Name or or Drug Name.
    • Availability: May indicate if the item is available over the counter (OTC), May indicate if the item is available over the counter (OTC),
    discontinued, recalled, or in shortage. May be referred to as discontinued, recalled, or in shortage. May be referred to as Marketing Status.
    • Contact: Includes applicant, correspondent, or manufacturer on file with the Includes applicant, correspondent, or manufacturer on file with the
    FDA.
    • FDA.
  • Approval Date: May be referred to as Decision Date.
    • Dosage Form:    Approval Date:     May be referred to as Decision Date.

    22 CRS Report R41983, How FDA Approves Drugs and Regulates Their Safety and Effectiveness, by Hassan Z. Sheikh.
    23 For more information on the NDA process, see FDA, New Drug Application, https://www.fda.gov/drugs/types-
    applications/new-drug-application-nda.
    24 For more information on the BLA Process, see FDA, Biologics License Applications (BLA) Process (CBER),
    https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biologics-license-applications-bla-
    process-cber.
    25 21 C.F.R. §314.80; 21 C.F.R. §600.80(c).
    26 21 U.S.C. §355.
    27 See Table 1.
    Congressional Research Service

    9
    Finding Medical Device and Drug Approval Information Through the FDA Databases

    • Dosage Form: The physical form in which a drug is produced and dispensed,
    The physical form in which a drug is produced and dispensed, such as a tablet, a capsule, or an injectable.such as a tablet, a capsule, or an injectable.
    • Label: The FDA-approved label is the official description of a drug product that The FDA-approved label is the official description of a drug product that
    includes indication (what the drug is used for); who should take it; adverse events includes indication (what the drug is used for); who should take it; adverse events
    (side effects); instructions for uses in pregnancy, children, and other populations; (side effects); instructions for uses in pregnancy, children, and other populations;
    and safety information for the patient. Labels are often found inside drug product and safety information for the patient. Labels are often found inside drug product
    packaging.packaging.
    • Active Ingredient: The drug component that provides pharmacological activity The drug component that provides pharmacological activity
    or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention
    of disease, or to affect the structure or any function of the body of man or of disease, or to affect the structure or any function of the body of man or
    animals.animals.
    This table denotes the shortage and recall databases, given current congressional interest in the This table denotes the shortage and recall databases, given current congressional interest in the
    availability of these products.

    Congressional Research Service

    10
    link to page 15 link to page 15 link to page 15 link to page 15 link to page 15 link to page 15 link to page 15
    availability of these products. Table 3. Drugs and Biologics Databases
    (“+” ("+" indicates that types of data are included in database; indicates that types of data are included in database; “—”"—" indicates that types of data are not included in database. indicates that types of data are not included in database.
    Click on each database to navigate to the site.)Click on each database to navigate to the site.)

    Data

    Databasea

    Data

    Databasea    Example of database content and when
    to consult Proprietary
    Name

    Availability

    Contact

    Approval Date

    Dosage Form

    Labelb

    Active Ingredient

    Updated

    Drugs@FDA

    Is this drug FDA approved?

    +

    +

    +c

    +

    +

    +

    +

    Daily

    Approved Drug Products with     Approval
    Dosage
    Active
    to consult
    Name
    Availability
    Contact
    Date
    Form
    Labelb
    Ingredient
    Updated
    Drugs@FDA
    +
    +
    +c
    +
    +
    +
    +
    Daily
    Is this drug FDA approved?
    Approved Drug Products with
    +
    +
    +d
    +
    +
    —
    +
    Monthly
    Therapeutic Equivalence
    Evaluations (Orange Book)
    Is this drug available in the U.S.?
    Database of Licensed Biological
    +
    +
    +
    +
    +
    +
    +
    Monthly
    Products (Purple Book)

    +

    +

    +d

    +

    +

    —

    +

    Monthly

    Database of Licensed Biological Products (Purple Book)

    Is this biologic FDA approved?
    Approved Risk Evaluation and
    +
    —
    —
    —f
    +
    —
    +
    As needed
    Mitigation Strategies (REMS)e
    Is this drug in the REMS program?
    Drug Establishments Current
    —
    —
    +
    —
    —
    —
    —
    Daily
    Registration Site
    Where is a drug manufacturer located?
    FDA Adverse Event Reporting
    +
    —
    —
    —
    —
    —
    —
    Quarterly
    System (FAERS) Public
    Dashboard

    +

    +

    +

    +

    +

    +

    +

    Monthly

    Approved Risk Evaluation and Mitigation Strategies (REMS)e

    Is this drug in the REMS program?

    +

    —

    — —f

    +

    —

    +

    As needed

    Drug Establishments Current Registration Site

    Where is a drug manufacturer located?

    —

    —

    +

    —

    —

    —

    —

    Daily

    FDA Adverse Event Reporting System (FAERS) Public Dashboard

    Are there adverse reactions associated
    with this drug?
    Postmarket Requirements and
    +
    —
    +g
    +
    —
    —
    +
    Quarterly
    Commitments

    +

    —

    —

    —

    —

    —

    —

    Quarterly

    Postmarket Requirements and Commitments

    Are there statutory requirements
    associated with this product?
    CRS-11
    link to page 15 link to page 15 link to page 15

    Data

    Databasea
    Example of database content and when
    Proprietary
    Approval
    Dosage
    Active
    to consult
    Name
    Availability
    Contact
    Date
    Form
    Labelb
    Ingredient
    Updated
    Drug Shortages and Recalls
    FDA Drug Shortages
    +
    +
    +
    —
    +
    —
    +
    Updated daily
    Is this drug currently in shortage?
    CBER-Regulated Products
    +
    +
    +
    —
    +
    —
    —
    As needed.
    Shortages
    Is this CBER regulated product in
    shortage?
    Drug Recalls
    +
    +
    +c
    —
    +
    —
    —
    Weekly
    Has the manufacturer recalled this
    drug?

    +

    —

    +g

    +

    —

    —

    +

    Quarterly

    Drug Shortages and Recalls

    FDA Drug Shortages

    Is this drug currently in shortage?

    +

    +

    +

    —

    +

    —

    +

    Updated daily

    CBER-Regulated Products Shortages

    Is this CBER regulated product in shortage?

    +

    +

    +

    —

    +

    —

    —

    As needed.

    Drug Recalls

    Has the manufacturer recalled this drug?

    +

    +

    +c

    —

    +

    —

    —

    Weekly

     Source: Compiled by CRS based on information from FDA.gov.Compiled by CRS based on information from FDA.gov.
    a. a. Database name in bold.Database name in bold.
    b. b. Also see Also see FDA Label Search database, https://labels.fda.gov/proprietaryname.cfm database, https://labels.fda.gov/proprietaryname.cfm.
    c. . c. Company name is listed but does not include contact information in the entry.Company name is listed but does not include contact information in the entry.
    d. d. Applicant Holder is listed but does not include contact information in the entry.Applicant Holder is listed but does not include contact information in the entry.
    e. e. Also see the Also see the REMS Public Dashboard, https://www.fda.gov/drugs/risk-evaluation-and-mitigation-strategies-rems/risk-evaluation-and-mitigation-strategy-rems-public-, https://www.fda.gov/drugs/risk-evaluation-and-mitigation-strategies-rems/risk-evaluation-and-mitigation-strategy-rems-public-
    dashboard.
    f.
    dashboard. f. REMS approval date.REMS approval date.
    g. g. Applicant name is listed but does not include contact information in the entry.Applicant name is listed but does not include contact information in the entry.
    CRS-12
    Finding Medical Device and Drug Approval Information Through the FDA Databases

    Additional CRS Resources
    • CRS Report R41983, CRS Report R41983, How FDA Approves Drugs and Regulates Their Safety and
    Effectiveness
    • CRS In Focus IF11083, CRS In Focus IF11083, Medical Product Regulation: Drugs, Biologics, and
    Devices Devices
    • CRS Report R47374, CRS Report R47374, FDA Regulation of Medical Devices
    • CRS In Focus IF11379, CRS In Focus IF11379, Medical Product Innovation and Regulation: Benefits
    and Risks
    • CRS In Focus IF11389, CRS In Focus IF11389, FDA Regulation of Laboratory-Developed Tests (LDTs)
    • CRS Report R46985, CRS Report R46985, FDA Regulation of Over-the-Counter (OTC) Drugs:
    Overview and Issues for Congress
    • CRS In Focus IF11058, CRS In Focus IF11058, Drug Shortages: Causes, FDA Authority, and Policy
    Options
    Congressional Research Service

    13
    Finding Medical Device and Drug Approval Information Through the FDA Databases

    Appendix. Glossary
    • Options Appendix. GlossaryApplicant. Manufacturer or sponsor submitting required paperwork to FDA. Manufacturer or sponsor submitting required paperwork to FDA.
    • Approved Risk Evaluation and Mitigation Strategies (REMS). 21 U.S.C. 21 U.S.C.
    §355-1 establishes FDA§355-1 establishes FDA’'s REMS authority. A REMS is a required risk s REMS authority. A REMS is a required risk
    management strategy that can include one or more elements to ensure that the management strategy that can include one or more elements to ensure that the
    benefits of a drug outweigh its risks.benefits of a drug outweigh its risks.
    • De De Novo Classification. An alternate pathway to reclassify new moderate- or An alternate pathway to reclassify new moderate- or
    low-risk medical devices automatically placed in Class III to either Class I or low-risk medical devices automatically placed in Class III to either Class I or
    Class II after receiving a not substantially equivalent (NSE) determination in Class II after receiving a not substantially equivalent (NSE) determination in
    response to a 510(k) submission. The Food and Drug Administration Safety and response to a 510(k) submission. The Food and Drug Administration Safety and
    Innovation Act (FDASIA) provided a second pathway allowing a sponsor to Innovation Act (FDASIA) provided a second pathway allowing a sponsor to
    submit a de novo classification request to the FDA without first being required to submit a de novo classification request to the FDA without first being required to
    submit a 510(k). If the classification request is approved, FDA grants the device-submit a 510(k). If the classification request is approved, FDA grants the device-
    marketing authorization and creates a new generic device type, allowing the marketing authorization and creates a new generic device type, allowing the
    device to serve as a predicate device for 510(k) submissions in the future (21 device to serve as a predicate device for 510(k) submissions in the future (21
    C.F.R. §860.200).C.F.R. §860.200).
    • Humanitarian Use Device (HUD). A medical device intended to benefit patients A medical device intended to benefit patients
    in the treatment or diagnosis of a disease or condition that affects or is manifested in the treatment or diagnosis of a disease or condition that affects or is manifested
    in not more than 8,000 individuals in the United States per year (21 in not more than 8,000 individuals in the United States per year (21 USC
    U.S.C. §360j(m)).§360j(m)).
    • Humanitarian Device Exemption (HDE).. A marketing application for an HUD; A marketing application for an HUD;
    it is exempt from the effectiveness requirements of Sections 514 and 515 of the it is exempt from the effectiveness requirements of Sections 514 and 515 of the
    FFDCA and is subject to certain profit and use restrictions.FFDCA and is subject to certain profit and use restrictions.
    • Marketing StatusStatus. Indicates how a product is sold in the United States. Indicates how a product is sold in the United States.
    • Postmarket Requirements and Commitments.. Refers to studies and clinical Refers to studies and clinical
    trials that sponsors conduct after FDA approval to gather additional information trials that sponsors conduct after FDA approval to gather additional information
    about a productabout a product’'s safety, efficacy, or optimal use.s safety, efficacy, or optimal use.
    • Premarket Approval Approval (PMA). FDA process of scientific and regulatory review FDA process of scientific and regulatory review
    to evaluate the safety and effectiveness of Class III medical devices, which are to evaluate the safety and effectiveness of Class III medical devices, which are
    medical devices that support or sustain human life, are of substantial importance medical devices that support or sustain human life, are of substantial importance
    in preventing impairment of human health, or which present a potential, in preventing impairment of human health, or which present a potential,
    unreasonable risk of illness or injury (21 C.F.R. §814). If successful, this results unreasonable risk of illness or injury (21 C.F.R. §814). If successful, this results
    in an in an approval..
    • Premarket Notification 510(k). A 510(k) is a premarket submission made to A 510(k) is a premarket submission made to
    FDA to demonstrate that the device to be marketed is as safe and effective, or is FDA to demonstrate that the device to be marketed is as safe and effective, or is
    substantially equivalent, to a legally marketed device not subject to premarket substantially equivalent, to a legally marketed device not subject to premarket
    approval (21 C.F.R. §807 Subpart E). If successful, this results in a approval (21 C.F.R. §807 Subpart E). If successful, this results in a clearance.
    • Product Development Protocol.. In the product development protocol (PDP) In the product development protocol (PDP)
    method for gaining marketing approval, the clinical evaluation of a device and method for gaining marketing approval, the clinical evaluation of a device and
    the development of necessary information for marketing approval are merged the development of necessary information for marketing approval are merged
    into one regulatory mechanism.into one regulatory mechanism.2829 A Class III device for which a PDP has been A Class III device for which a PDP has been
    declared completed by FDA under will be considered to have an approved PMA declared completed by FDA under will be considered to have an approved PMA
    (21 C.F.R. §814.19).

    28 FDA, PMA Application Methods, https://www.fda.gov/medical-devices/premarket-approval-pma/pma-application-
    methods.
    Congressional Research Service

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    Finding Medical Device and Drug Approval Information Through the FDA Databases

    • Sponsor (Drug).(21 C.F.R. §814.19). Sponsor (Drug). A person who takes responsibility for and initiates a clinical A person who takes responsibility for and initiates a clinical
    investigation. The sponsor may be an individual or pharmaceutical company, investigation. The sponsor may be an individual or pharmaceutical company,
    governmental agency, academic institution, private organization, or other governmental agency, academic institution, private organization, or other
    organization. The sponsor does not actually conduct the investigation unless the organization. The sponsor does not actually conduct the investigation unless the
    sponsor is a sponsor-investigator. A person other than an individual that uses one sponsor is a sponsor-investigator. A person other than an individual that uses one
    or more of its own employees to conduct an investigation that it has initiated is a or more of its own employees to conduct an investigation that it has initiated is a
    sponsor, not a sponsor-investigator, and the employees are investigators (21 sponsor, not a sponsor-investigator, and the employees are investigators (21
    C.F.R. §312.3(b)).C.F.R. §312.3(b)).
    • Sponsor (Device).. A person who initiates, but who does not actually conduct, the A person who initiates, but who does not actually conduct, the
    investigation; that is, the investigational device is administered, dispensed, or investigation; that is, the investigational device is administered, dispensed, or
    used under the immediate direction of another individual. A person other than an used under the immediate direction of another individual. A person other than an
    individual that uses one or more of its own employees to conduct an investigation individual that uses one or more of its own employees to conduct an investigation
    that it has initiated is a sponsor, not a sponsor-investigator, and the employees are that it has initiated is a sponsor, not a sponsor-investigator, and the employees are
    investigators (21 C.F.R. §812.3(n)).investigators (21 C.F.R. §812.3(n)).


    Author Information

    Kate M. Costin

    Research Librarian


    Acknowledgments
    Amanda Sarata, Specialist in Health Policy; Hassan Sheikh, Analyst in Health Policy; and Michele Malloy, Amanda Sarata, Specialist in Health Policy; Hassan Sheikh, Analyst in Health Policy; and Michele Malloy,
    Senior Research Librarian, contributed to this report.Senior Research Librarian, contributed to this report.


    Disclaimer
    This document was prepared by the Congressional Research Service (CRS). CRS serves as nonpartisan
    shared staff to congressional committees and Members of Congress. It operates solely at the behest of and
    under the direction of Congress. Information in a CRS Report should not be relied upon for purposes other
    than public understanding of information that has been provided by CRS to Members of Congress in
    connection with CRS’s institutional role. CRS Reports, as a work of the United States Government, are not
    subject to copyright protection in the United States. Any CRS Report may be reproduced and distributed in
    its entirety without permission from CRS. However, as a CRS Report may include copyrighted images or
    material from a third party, you may need to obtain the permission of the copyright holder if you wish to
    copy or otherwise use copyrighted material.

    Congressional Research Service
    R48133 · VERSION 1 · NEW
    15

    Footnotes

    1.

    Regulations promulgated pursuant to these statutory requirements are generally found in the Code of Federal Regulations (C.F.R.), Title 21—Food and Drugs.

    2.

    Marketing status indicates how a product is sold in the United States (e.g., prescription, over-the-counter).

    3.

    FDA is restricted by regulation as to what it may publicly disclose with respect to commercial confidential information (CCI). See 21 C.F.R. §807.95.

    4.

    CRS Report 98-446, Congressional Liaison Offices of Selected Federal Agencies, by Audrey Celeste Crane-Hirsch.

    5.

    FDA, What We Do, https://www.fda.gov/about-fda/what-we-do.

    6.

    Within the Code of Federal Regulations, see for drugs, 21 C.F.R. §314; for devices, see 21 C.F.R. Part 807, Subpart E (510(k) clearance); 21 C.F.R. Part 814 (Premarket Approval); 21 C.F.R. Part 860, Subpart D (De Novo Request for Classification). Biological products are licensed under Section 351 of the PHSA; some therapeutic protein products are approved under Section 505 of the FFDCA.

    7.

    CRS Report R41983, How FDA Approves Drugs and Regulates Their Safety and Effectiveness, by Hassan Z. Sheikh.

    8.

    CRS In Focus IF11083, Medical Product Regulation: Drugs, Biologics, and Devices, by Amanda K. Sarata and Hassan Z. Sheikh.

    9.

    Certain biological products, such as hormonal products, are regulated under FFDCA For more information, see FDA, Frequently Asked Questions About Therapeutic Biological Products, https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/frequently-asked-questions-about-therapeutic-biological-products.

    10.

    FDA, FDA Organizations Chart, https://www.fda.gov/about-fda/fda-organization/fda-organization-charts. In March 2025, the Secretary of Health and Human Services announced restructuring that includes FDA. At this report's publication, the potential effects of restructuring within FDA are unknown.

    11.

    For more information on the categories of therapeutic biological products regulated by CDER (under the FFDCA and/or the PHSA, as appropriate), see FDA, Frequently Asked Questions About Therapeutic Biological Products, https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/frequently-asked-questions-about-therapeutic-biological-products.

    12.

    CRS In Focus IF11083, Medical Product Regulation: Drugs, Biologics, and Devices, by Amanda K. Sarata and Hassan Z. Sheikh.

    13.

    CRS Report R47374, FDA Regulation of Medical Devices, by Amanda K. Sarata.

    14.

    HHS, "HHS Announces Transformation to Make America Healthy Again," press release, March 27, 2025, https://www.hhs.gov/press-room/hhs-restructuring-doge.html. HHS, "Fact Sheet: HHS' Transformation to Make America Healthy Again," press release, March 27, 2025, https://www.hhs.gov/press-room/hhs-restructuring-doge-fact-sheet.html.

    15.

    CRS Report R47374, FDA Regulation of Medical Devices, by Amanda K. Sarata.

    16.

    FFDCA §513(a)(1)(A); 21 U.S.C. §360c(a)(1)(A).

    17.

    FFDCA §513(a)(1)(B); 21 U.S.C. §360c(a)(1)(B).

    18.

    FFDCA §513(a)(1)(C); 21 U.S.C. §360c(a)(1)(C).

    19.

    21 C.F.R. §807.92.

    20.

    CRS In Focus IF11083, Medical Product Regulation: Drugs, Biologics, and Devices, by Amanda K. Sarata and Hassan Z. Sheikh.

    21.

    FDA, Post-Approval Studies (PAS) Database, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma_pas.cfm.

    22.

    21 C.F.R. §807.92; FDA, Device Approvals and Clearances, https://www.fda.gov/medical-devices/products-and-medical-procedures/device-approvals-and-clearances.

    23.

    CRS Report R41983, How FDA Approves Drugs and Regulates Their Safety and Effectiveness, by Hassan Z. Sheikh.

    24.

    For more information on the NDA process, see FDA, New Drug Application, https://www.fda.gov/drugs/types-applications/new-drug-application-nda.

    25.

    For more information on the BLA Process, see FDA, Biologics License Applications (BLA) Process (CBER), https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biologics-license-applications-bla-process-cber.

    26.

    21 C.F.R. §314.80; 21 C.F.R. §600.80(c).

    27.

    21 U.S.C. §355.

    28. See Table 1. 29.

    FDA, PMA Application Methods, https://www.fda.gov/medical-devices/premarket-approval-pma/pma-application-methods.