Medical Devices & Consumer Health Products 2021: Trends & Developments – Food, Drugs, Healthcare, Life Sciences

Medical Devices & Consumer Health Products 2021: Trends & Developments – Food, Drugs, Healthcare, Life Sciences

October 3, 2021 Off By administrator


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1. APPLICABLE PRODUCT SAFETY REGULATORY REGIMES

1.1 Medical Devices

The Federal Food, Drug, and Cosmetic Act (FDCA) and the Public
Health Service Act (PHSA) are the two key statutes governing the
development, manufacturing, distribution, registration, licensing,
clearance and approval of such products in the USA. The U.S. Food
and Drug Administration (FDA) is the federal administrative agency
with primary authority for ensuring such products are safe and
effective for their intended uses by enforcing the FDCA. The FDA
issues regulations and guidance documents further detailing and
interpreting requirements of the FDCA. The relevant regulations are
located in Title 21 of the U.S. Code of Federal Regulations.

The Federal Trade Commission (FTC) is the primary federal agency
responsible for policing unfair, deceptive and anticompetitive
advertising, and other business practices, including in the medical
products industry. Through a Memorandum of Understanding, and as
discussed further, the FDA and FTC share jurisdiction over the
regulation of medical devices and certain other medical products.
The FTC’s primary statutory authority is the U.S. Federal Trade
Commission Act, which, among other things, prohibits unfair or
deceptive advertising. Numerous states have implemented their own
similar consumer protection/unfair or deceptive advertising
statutes. Moreover, many states have laws regulating the
manufacturing and distribution of prescription medical devices and
the storage and distribution of human tissue products.

The FDA regulates products as medical devices based on their
“intended use(s)”. A product’s intended use refers to
“the objective intent of the persons legally responsible for
the labeling of devices”; see 21 C.F.R. § 801.4. Such
objective intent can be shown by, among other things:

  • labelling claims;

  • advertisements;

  • oral or written statements by a manufacturer or its
    representatives; and

  • circumstances surrounding a product’s distribution.

The FDCA defines a “device” to mean, in relevant part,
an “instrument, apparatus, implement, machine, contrivance,
implant in vitro reagent or other similar or related article,
including any component, part, or accessory [that is] (1) intended
for use in the diagnosis of disease or other conditions, or in the
cure, mitigation, treatment, or prevention of disease, in man or
other animals, or (2) intended to affect the structure or any
function of the body of man or other animals, and which does not
achieve its primary intended purposes through chemical action
within or on the body of man or other animals and which is not
dependent upon being metabolized for the achievement of its primary
intended purposes”; see 21 U.S.C. § 321(h).

Where a product falls within the scope of this statutory
definition, the FDA may…

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