Regulation of
Medical Devices in the United States
Our COVID-19 self-test kits and operations are subject to extensive
and ongoing regulation by the FDA under the Federal Food, Drug, and
Cosmetic Act and its implementing regulations, collectively
referred to as the FDCA, as well as other federal and state
regulatory bodies in the United States. The laws and regulations
govern, among other things, product design and development,
pre-clinical and clinical testing, manufacturing, packaging,
labeling, storage, record keeping and reporting, clearance or
approval, marketing, distribution, promotion, import and export and
post-marketing surveillance.
The FDA regulates the development, design, pre-clinical and
clinical research, manufacturing, safety, efficacy, labeling,
packaging, storage, installation, servicing, recordkeeping,
premarket clearance or approval, import, export, adverse event
reporting, advertising, promotion, marketing and distribution of
medical devices in the United States to ensure that medical devices
distributed domestically are safe and effective for their intended
uses and otherwise meet the requirements of the FDCA. Failure to
comply with applicable requirements may subject a device and/or its
manufacturer to a variety of administrative sanctions, such as FDA
refusal to approve pending premarket applications, issuance of
warning letters, mandatory product recalls, import detentions,
civil monetary penalties, and/or judicial sanctions, such as
product seizures, injunctions and criminal prosecution.
FDA Premarket Clearance and Approval
Requirements
Unless an exemption applies, each medical device commercially
distributed in the United States requires either FDA clearance of a
510(k) premarket notification, approval of a premarket approval, or
PMA, or grant of a de novo request for classification. During
public emergencies, FDA also may grant emergency use authorizations
to allow commercial distribution of devices intended to address the
public health emergency. Under the FDCA, medical devices are
classified into one of three classes-Class I, Class II or Class
III-depending on the degree of risk associated with each medical
device and the extent of manufacturer and regulatory control needed
to provide reasonable assurance of its safety and effectiveness.
Classification of a device is important because the class to which
a device is assigned determines, among other things, the necessity
and type of FDA review required prior to marketing the device.
Class I devices include those with the lowest risk to the patient
and are those for which safety and effectiveness can be reasonably
assured by adherence to the FDA’s “general controls” for medical
devices, which include compliance with the applicable portions of
the FDA’s Quality System Regulation, or QSR, facility registration
and product listing, reporting of adverse medical events and
malfunctions through the submission of Medical Device Reports, or
MDRs, and appropriate, truthful and non-misleading labeling,
advertising, and promotional materials. Some Class I or low risk
devices also require premarket clearance by the FDA through the
510(k) premarket notification process described below.
Class II devices are moderate risk devices subject to the FDA’s
general controls, and any other “special controls” deemed necessary
by the FDA to ensure the safety and effectiveness of the device,
such as performance standards, product-specific guidance documents,
special labeling requirements, patient registries or post-market
surveillance. Premarket review and clearance by the FDA for Class
II devices is accomplished through the 510(k) premarket
notification process, though certain Class II devices are exempt
from this premarket review process. When required, the manufacturer
must submit to the FDA a premarket notification, or 510(k),
submission demonstrating that the device is “substantially
equivalent” to a legally marketed predicate device, which in some
cases may require submission of clinical data. Unless a specific
exemption applies, 510(k) premarket notification submissions are
subject to user fees. If the FDA determines that the device, or its
intended use, is not substantially equivalent to a legally marketed
device, the FDA will place the device, or the particular use of the
device, into Class III, and the device sponsor must then fulfill
more rigorous premarketing requirements.
Class III devices include devices deemed by the FDA to pose the
greatest risk, such as life-sustaining, life-supporting or
implantable devices and devices deemed not substantially equivalent
to a predicate device following a 510(k) submission. The safety and
effectiveness of Class III devices cannot be reasonably assured
solely by general or special controls. Submission and FDA approval
of a PMA application is required before marketing of a Class III
device can proceed. As with 510(k) submissions, unless an exemption
applies, PMA submissions are subject to user fees. The PMA process
is much more demanding than the 510(k) premarket notification
process. A PMA application, which is intended to demonstrate that
the device is reasonably safe and effective for its intended use
and must be supported by extensive data, typically including data
from pre-clinical studies and clinical trials.