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

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

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

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

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
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.
Congressional staff may consult the FDA’s catalog of databases to identify information on a medical device or
drug’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
particular product, and monitoring notification of product shortage or recall.
Since there is not a single, searchable platform on the FDA’s website that allows users to search across the
agency’s entire catalog of databases, this 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
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
database, and each database’s currency. Data availability and accessibility will vary depending on the scope, types
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
products, brief summaries of the FDA’s approval processes for medical devices and drugs, references to additional
CRS products on the FDA’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

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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
databases containing information vital to the agency’s regulatory oversight of the medical device
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
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.1
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
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
agency.
Congressional staff may need to consult the FDA’s collection of databases in order to identify
information related to medical products, including
• current product availability (e.g., in shortage),
• current FDA device and drug marketing status,2
• current FDA device classification,
• adverse event(s) reporting, and
• manufacturer (including contact information).
There is not a single, searchable platform on the FDA’s website that allows users to search across
the agency’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.
Relevant data are also presented in a variety of formats on the FDA’s website. For example, some
data are accessible through interactive tables (e.g., Drug Recalls), while other data are housed in
standalone databases on the website https://www.accessdata.fda.gov/. For the purpose of this
report, all data repositories on the FDA’s website will be referred to as a database.
This report provides examples and is not a comprehensive listing of all FDA databases. The data’s
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
database, the types of data maintained in the database, and the database’s frequency of update.
The information provided for each database is not exhaustive and is meant only to illustrate its
available content.
Finally, while the phrases premarket and postmarket data are used throughout this report, it is
important to note that, in general, data for products currently undergoing FDA review are not
available publicly through the FDA’s website.3 The information used to populate these databases
is obtained through premarket submissions publicly released after FDA marketing authorization is
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
contacting the FDA congressional liaison.4
For definitions of terms used throughout this report, see the Appendix.
FDA Regulation of Drugs and Medical Devices
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,
biological products, medical devices, and radiation emitting products in the United States.5 Under
most circumstances, drugs, devices, and biologics may be marketed in the United States only if
they have been approved, cleared, or licensed by FDA.6 In the premarket approval phase, the
FDA reviews manufacturers’ 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
postmarket approval phase lasts as long as the item is in the market.7
In general, drugs and devices are approved or cleared under the FFDCA,8 whereas biologics are
licensed under the PHSA.9 For further information related to the FDA’s approval and regulation
processes of drugs and medical devices, see CRS Report R41983, How FDA Approves Drugs and
Regulates Their Safety and Effectiveness, and CRS Report R47374, FDA Regulation of Medical
Devices. In addition, the CRS In Focus IF11083, Medical Product Regulation: Drugs, Biologics,
and Devices, broadly summarizes selected differences in statutory requirements among drugs,
biologics, and devices.
The FDA consists of nine center-level organizations and 13 headquarter (HQ) offices.10 Within
the FDA, the following centers oversee drugs, biologics, and devices:
• Center for Biologics Evaluation and Research (CBER) oversees certain biologics
(e.g., vaccines and gene therapies).
• 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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• Center for Devices and Radiological Health (CDRH) oversees medical devices
and radiologic products.12
These centers are responsible for maintaining the publicly available databases on the FDA’s
website corresponding with their industries of oversight. Table 1 lists the databases included in
this report, with the center(s) responsible for each database’s maintenance. Given that some
centers may have overlapping authority over certain medical products (e.g., combination
products-therapeutic or diagnostic products that combine drugs, biologics, and devices),13 some
databases appear in multiple columns.
Table 1. Databases Maintained by FDA Centers
The following table provides a list of select FDA databases organized by the FDA centers responsible for
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
•
MAUDE (Manufacturer and
User Facility Device
•
FDA Drug Shortages
Experience)
•
Drug Recallsc
•
Post-Approval Studies (PAS)
Database
•
Total Product Life Cycle
(TPLC)
Source: Compiled by CRS based on information from FDA.gov.
a. 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.
b. Allows user to narrow search by FDA Center (e.g., CBER or CDRH).
c. 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
sold in the United States.14 Additionally, CDRH regulates radiation-emitting electronic products
(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
are classified into the following categories.
• Class I medical devices are considered low risk. As such, general controls are
considered sufficient to provide reasonable assurance of safety and
effectiveness.15
• Class II medical devices are considered moderate risk; therefore, general and
special controls are considered to provide reasonable assurance of safety and
effectiveness.16
• 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
and effectiveness.17
Unless specifically excluded by regulation, all devices must meet general controls. These include
both premarket and postmarket requirements. General controls include 510(k) premarket
notification,18 registration, listing, and compliance with current good manufacturing practices as
set forth in FDA’s quality system regulations.19 CRS Report R47374, FDA Regulation of Medical
Devices, provides further information on the FDA device classification processes and device
regulatory controls.
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
premarket approval (PMA), humanitarian device exemption (HDE), or product development
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
effectiveness (or continued probable benefit, in the case of an HDE) of approved medical
devices.20
FDA databases include information associated with a specific medical device, such as the name
of a product’s manufacturer, the device’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
FDA.
Table 2 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.
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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• Proprietary Name: Name of device on record with the FDA. May also be listed
as Device Name in select databases.
• Decision Date: Date of approval on record with the FDA. May be referred to as
Approval Date in select databases.
• Contact: This information may be recorded as the Applicant, Correspondent,
Owner/Operator, or Manufacturer on file with the FDA.
• Class: Medical device classification assigned by the FDA. Device may be
considered Class I, Class II, or Class III.
• 510(k) Number: 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
substantially equivalent (SE), to a legally marketed device that is not subject to
premarket approval (PMA).21
• Regulation Number: A device’s regulation number in the Code of Federal
Regulations. 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
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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Table 2. Medical Devices Databases
(“+” indicates that types of data are included in database; “—” indicates that types of data are not included in database.
Click on each database to navigate to the site.)

Data

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
What company manufactures
this device?
Which devices are made by this
manufacturer?
Devices@FDA
+
+
+
—
+
+
Weekly
Is this device FDA approved or
cleared?
Product Classification
—
—
—
+
—d
+
Weekly
Database
What is this device’s FDA
classification?
510(k) Premarket
+
+
+
—
+
+
Weekly
Notification
Is this device cleared?
Device Classification
+
+
+
—
—
+
Weekly
Under Section 513(f)(2)
(De Novo)e
Does this device have a De
Novo number?
Premarket Approval
+
+
+
—
—
—
Weekly
(PMA)
When was this Class III device
approved?
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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
Facility Device
Experience (MAUDE)
Are there adverse events
reported for this device?
Post-Approval Studies
+
+
+
—
—
—
Weekly
(PAS) Database
Were there PAS required for
this device?
Total Product Life Cycle
+
—
—h
+
—
+
Weekly
(TPLC)
Are there any postmarket FDA
actions associated with this
device?
Source: Compiled by CRS based on information from FDA.gov.
a. Database name in bold.
b. Registration and Listing does not denote approval or clearance of a firm or their device(s) by the FDA.
c. Premarket Submission Number (if available).
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d. Submission Type will note 510(k) submission, if applicable.
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)
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).
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
authority for certification and oversight of clinical laboratories and laboratory testing.
g. Manufacturer name is listed but does not include contact information in the entry.
h. Manufacturer name may be listed but does not include contact information in the entry.

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Drugs and Biologics Databases
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
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
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
same as the brand-name drug.22
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
the sponsor’s proposed labeling.23
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
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
Strategies).24
For both drugs and biologics, manufacturers must report all serious and unexpected adverse
events to FDA within 15 days of becoming aware of them.25 Clinicians and patients may report
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,
and can require labeling changes based on information it gathers from mandatory and voluntary
adverse event reports.26
Table 3 provides select information for several FDA databases containing drug data maintained
by CBER and CDER.27 For each entry, Table 3 lists the circumstance in which a user might
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.
• Proprietary Name: Name on record with the FDA. May also listed as Trade
Name or Drug Name.
• Availability: May indicate if the item is available over the counter (OTC),
discontinued, recalled, or in shortage. May be referred to as Marketing Status.
• Contact: Includes applicant, correspondent, or manufacturer on file with the
FDA.
• 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.
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• Dosage Form: The physical form in which a drug is produced and dispensed,
such as a tablet, a capsule, or an injectable.
• Label: 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
(side effects); instructions for uses in pregnancy, children, and other populations;
and safety information for the patient. Labels are often found inside drug product
packaging.
• Active Ingredient: The drug component that provides pharmacological activity
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
animals.
This table denotes the shortage and recall databases, given current congressional interest in the
availability of these products.

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Table 3. Drugs and Biologics Databases
(“+” indicates that types of data are included in database; “—” indicates that types of data are not included in database.
Click on each database to navigate to the site.)

Data

Databasea
Example of database content and when
Proprietary
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)
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
Are there adverse reactions associated
with this drug?
Postmarket Requirements and
+
—
+g
+
—
—
+
Quarterly
Commitments
Are there statutory requirements
associated with this product?
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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?
Source: Compiled by CRS based on information from FDA.gov.
a. Database name in bold.
b. Also see FDA Label Search database, https://labels.fda.gov/proprietaryname.cfm.
c. Company name is listed but does not include contact information in the entry.
d. Applicant Holder is listed but does not include contact information in the entry.
e. Also see the REMS Public Dashboard, https://www.fda.gov/drugs/risk-evaluation-and-mitigation-strategies-rems/risk-evaluation-and-mitigation-strategy-rems-public-
dashboard.
f.
REMS approval date.
g. Applicant name is listed but does not include contact information in the entry.
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Finding Medical Device and Drug Approval Information Through the FDA Databases

Additional CRS Resources
• CRS Report R41983, How FDA Approves Drugs and Regulates Their Safety and
Effectiveness
• CRS In Focus IF11083, Medical Product Regulation: Drugs, Biologics, and
Devices
• CRS Report R47374, FDA Regulation of Medical Devices
• CRS In Focus IF11379, Medical Product Innovation and Regulation: Benefits
and Risks
• CRS In Focus IF11389, FDA Regulation of Laboratory-Developed Tests (LDTs)
• CRS Report R46985, FDA Regulation of Over-the-Counter (OTC) Drugs:
Overview and Issues for Congress
• CRS In Focus IF11058, Drug Shortages: Causes, FDA Authority, and Policy
Options
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Appendix. Glossary
• Applicant. Manufacturer or sponsor submitting required paperwork to FDA.
• Approved Risk Evaluation and Mitigation Strategies (REMS). 21 U.S.C.
§355-1 establishes FDA’s REMS authority. A REMS is a required risk
management strategy that can include one or more elements to ensure that the
benefits of a drug outweigh its risks.
• De Novo Classification. An alternate pathway to reclassify new moderate- 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
response to a 510(k) submission. The Food and Drug Administration Safety and
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 510(k). If the classification request is approved, FDA grants the device-
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
C.F.R. §860.200).
• Humanitarian Use Device (HUD). A medical device intended to benefit patients
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 USC
§360j(m)).
• Humanitarian Device Exemption (HDE). A marketing application for an HUD;
it is exempt from the effectiveness requirements of Sections 514 and 515 of the
FFDCA and is subject to certain profit and use restrictions.
• Marketing Status. Indicates how a product is sold in the United States.
• Postmarket Requirements and Commitments. Refers to studies and clinical
trials that sponsors conduct after FDA approval to gather additional information
about a product’s safety, efficacy, or optimal use.
• Premarket Approval (PMA). FDA process of scientific and regulatory review
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
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
in an approval.
• Premarket Notification 510(k). 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
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 clearance.
• Product Development Protocol. In the product development protocol (PDP)
method for gaining marketing approval, the clinical evaluation of a device and
the development of necessary information for marketing approval are merged
into one regulatory mechanism.28 A Class III device for which a PDP has been
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.
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Finding Medical Device and Drug Approval Information Through the FDA Databases

• Sponsor (Drug). A person who takes responsibility for and initiates a clinical
investigation. The sponsor may be an individual or pharmaceutical company,
governmental agency, academic institution, private organization, or other
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
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
C.F.R. §312.3(b)).
• Sponsor (Device). A person who initiates, but who does not actually conduct, the
investigation; that is, the investigational device is administered, dispensed, or
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
that it has initiated is a sponsor, not a sponsor-investigator, and the employees are
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,
Senior Research Librarian, contributed to this report.

Disclaimer
This document was prepared by the Congressional Research Service (CRS). CRS serves as nonpartisan
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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
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Congressional Research Service
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