Updated September 29, 2021
Medical Product Regulation: Drugs, Biologics, and Devices
The Food and Drug Administration (FDA) regulates the
submission of an NDA, which may include restrictions on
safety and effectiveness of drugs, biologics, and devices
distribution or use of the drug.
(“medical products”) pursuant to its authorities under the
Federal Food, Drug and Cosmetic Act (FFDCA) and the
While drugs are approved via an NDA under Section 505 of
Public Health Service Act (PHSA). Drugs and devices are
the FFDCA, biologics are licensed via a biologics license
approved or cleared under the FFDCA, whereas biologics
application (BLA) under Section 351 of the PHSA. To
are licensed under the PHSA. Small molecule or chemical
obtain licensure, the sponsor must demonstrate in the BLA
drugs are chemically synthesized, while biologics are
that the biologic and the facilities and processes for
derived from living organisms. All FDA-regulated medical
manufacturing the product are safe, pure, and potent (i.e.,
products conceptually meet the definition of “drug.”
effective). The requirements and review pathway for BLAs
Biologics are a subset of drugs, subject to many of the same
are generally similar to that for NDAs, and biologics are
regulatory requirements. A device—an instrument,
subject to certain FFDCA provisions (e.g., REMS).
apparatus, implement, machine, contrivance, implant, in
vitro reagent, or other similar or related article—also meets
Medical Devices
the definition of “drug”; however, unlike a drug or biologic,
Medical devices are regulated based on the risk posed to the
it “does not achieve its primary intended purposes through
consumer: Class I devices are low-risk, Class II devices are
chemical action within or on the body ... and is not
moderate-risk, and Class III devices are high-risk. Unless
dependent upon being metabolized for the achievement of
specifically excluded by regulation, all devices must meet
its primary intended purposes” (FFDCA Section 201(h)).
general controls, which include both premarket and
FDA’s Center for Biologics Evaluation and Research
postmarket requirements. General controls include, for
(CBER) oversees certain biologics (e.g., vaccines and gene
example, 510(k) premarket notification, registration, and
therapies); the Center for Drug Evaluation and Research
listing and compliance with CGMPs as set forth in FDA’s
(CDER) oversees chemical drugs and therapeutic biologics;
quality system regulations (QSRs). Almost all Class I
and the Center for Devices and Radiological Health
devices are exempt from the 510(k) premarket notification
(CDRH) oversees medical devices and radiologic products.
requirement. In addition to general controls, Class II
devices must meet special controls, which are usually
This In Focus broadly summarizes selected differences in
device-specific. Premarket special controls include
statutory requirements among drugs, biologics, and devices.
performance standards and premarket data requirements.
It does not address every difference and is not meant to be a
Almost all Class II devices require 510(k) clearance,
comprehensive analysis of requirements.
demonstrating that a device is substantially equivalent to a
predicate device, prior to marketing. A 510(k) application
Premarket Requirements
typically does not require submission of clinical data. In
Under most circumstances, drugs, devices, and biologics
November 2018, FDA announced changes to modernize the
may be marketed only if they have been approved, cleared,
510(k) clearance pathway, including sunsetting certain
or licensed by FDA.
older predicate devices.
Prescription Drugs and Biologics
Class III devices are subject to premarket approval
To market a new drug, the sponsor (generally the
application (PMA) requirements, with some exceptions, in
manufacturer) must submit a new drug application (NDA)
addition to having to meet general controls. FDA issues an
demonstrating that the drug is safe and effective for its
approval order when a PMA demonstrates reasonable
proposed use. The law requires, among other things,
assurance that a device is safe and effective for its intended
substantial evidence of effectiveness, and the agency has
use(s). Effectiveness must be based on well-controlled
some discretion to determine what evidence is necessary for
investigations, which generally means clinical trial data.
NDA approval. During review, FDA officials evaluate the
However, the law provides that other evidence, when
drug’s safety and effectiveness for the intended use (derived
appropriate, may be used to establish effectiveness (e.g.,
from clinical trials); adequacy of manufacturing methods to
well-designed bench and/or animal testing) (FFDCA
ensure the drug’s identity, strength, quality, and purity; and
§513(a)(3)(B) and “The Least Burdensome Provisions of
accuracy of the proposed labeling. Sponsors must comply
the FDA Modernization Act of 1997”). Regardless of risk, a
with current good manufacturing practice (CGMP)
new device with no substantially equivalent predicate
regulations, which provide minimum requirements for the
device is automatically designated Class III unless the
methods, facilities, and controls used in manufacturing a
manufacturer submits a reclassification request or petition.
drug. For drugs with certain safety risks, FDA may require
The de novo pathway allows for certain lower-risk, novel
a risk evaluation and mitigation strategy (REMS) upon the
devices to be reclassified from Class III to Class I or II;
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Medical Product Regulation: Drugs, Biologics, and Devices
devices reviewed through this pathway successfully are
overlap with special controls for Class II devices but are
authorized for marketing.
generally more stringent and may include postapproval
studies; restriction of the sale, distribution or use of the
Figure 1.Select Premarket Requirements
device; and postapproval reports.
FDA can indirectly require a device labeling change by (1)
temporarily suspending a PMA approval order if, among
other things, the labeling is false or misleading (FFDCA
§515(e)), or (2) banning a device if it presents substantial
deception in the labeling (FFDCA §516(a)). (This is in
contrast to the authority for drugs, which allows FDA to
require a labeling change without affecting the drug’s
approval status.) FDA has mandatory recall authority over
medical devices (FFDCA §518(e)(1)).
Figure 2.Select Postmarket Requirements

Source: FFDCA, PHSA, and regulations at 21 C.F.R. Title 21.

Postmarket Requirements
Medical products are subject to various mandatory and
voluntary requirements once they are on the market.
Prescription Drugs and Biologics
Manufacturers must report all serious and unexpected

adverse events to FDA within 15 days of becoming aware
Source: FFDCA, PHSA, and regulations at 21 C.F.R. Title 21.

of them. Clinicians and patients may report adverse events
Product Classification Challenges
to the agency at any time. Once a drug is on the market,
FDA can require the manufacturer to conduct additional
Generally, a product that meets the statutory definition of a
studies or clinical trials based on newly acquired
drug or biologic and is assigned to CDER or CBER will
information, and can require labeling changes based on
have a higher standard of evidence, a potentially higher
information it gathers from mandatory and voluntary
requirement for supporting data, and a higher user fee than
adverse event reports (FFDCA §505(o)). FDA may require
a device assigned to CDRH. However, a product that is
a REMS after initial approval or licensing, if it becomes
classified as a drug and assigned to CDER or CBER may be
aware of certain new information and determines the REMS
eligible for certain benefits that would not be available for a
is necessary to ensure that the drug’s benefits outweigh the
product assigned to CDRH, such as data or market
risks. FDA conducts surveillance inspections once a drug is
protection in the form of regulatory exclusivity. At times,
on the market to assess compliance with manufacturing
there has been disagreement between FDA and product
standards, as well as for-cause inspections to investigate
sponsors regarding the jurisdictional determinations of
concerns about product quality. FDA also monitors product
certain drugs and devices and drug-device combination
integrity as a drug moves through the supply chain. FDA
products. For example, in 2019, Genus Medical
has mandatory recall authority over biologics, but generally
Technologies sued FDA for its decision to classify barium
not drugs. However, FFDCA §569D, added by P.L. 115-
sulfate contrast imaging agents as drugs rather than devices.
271, provides for the recall of a controlled substance that
In August 2021, FDA announced that following a decision
would cause serious adverse health consequences or death.
in that case, the agency could be requiring some approved
products to transition from drug to device status (86 FR
Medical Devices
43553). In addition, FDA notes that the agency intends to
Manufacturers must report device-related deaths, serious
regulate products that meet both the device and drug
injuries, and malfunctions within 30 days of becoming
definition as devices, except where statute indicates that
aware of them and must submit a report to FDA within five
Congress intended a different classification. As new
work days of becoming aware of (1) an event that requires
scientific evidence becomes available, FDA may reconsider
remedial action or (2) a reportable event for which FDA
previous determinations. For example, in December 2018,
made a written request. There are additional reporting
the agency announced its intent to reconsider classification
requirements for importers and user facilities (e.g.,
of certain hyaluronic acid (HA) intra-articular products that
hospitals). Clinicians and patients may report adverse
have been regulated as Class III devices and marketed
events to the agency at any time. Postmarket special
under a PMA (83 FR 64844). New evidence suggests that
controls for Class II devices include postmarket
HA achieves its primary intended purpose through chemical
surveillance (e.g., mandated studies) and patient registries.
action within the body, which may not meet the definition
For Class III devices, FDA may impose additional
of a device.
postapproval controls in a PMA approval order or by
regulation subsequent to approval. These controls may
Agata Bodie, Analyst in Health Policy
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Medical Product Regulation: Drugs, Biologics, and Devices

IF11083
Amanda K. Sarata, Specialist in Health Policy


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https://crsreports.congress.gov | IF11083 · VERSION 3 · UPDATED

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