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;
- 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 regulate such product as a medical device under the FDCA. In certain instances, the FDA has authority to exert "enforcement discretion" – that is, authority to not enforce some or all FDCA requirements against manufacturers of products which meet the definition of a medical device but which the FDA believes pose a low risk of harm to patients, either because of regulation through a parallel or complementary regulatory regime (such as in the case of certain in vitro diagnostic tests) or due to the inherent properties of the product (such as clinical decision support software which uses transparent, easy-to-understand inputs and outputs to assist a physician to track a patient's disease symptoms).
The FDA applies a risk-based classification to its regulation of medical devices. This means that a particular device's classification dictates the requirements applicable to its development, manufacture and commercialisation. The FDA places devices into three classes based on their risk.
Class I devices present the lowest level of risk and are those for which general controls (ie, basic FDA device authorities) are sufficient to provide reasonable assurance of such devices' safety and effectiveness.
Class II devices present a medium level of risk and are those for which general controls alone are not sufficient to provide reasonable assurance of such devices' safety and effectiveness, and for which there is sufficient information to establish special controls (ie, additional FDA device authorities, including performance standards) to provide such assurance.
Class III devices present the highest level of risk and are those 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.
1.2 Healthcare Products
The FDA also regulates cosmetics and food, including dietary supplements, under the FDCA. Although these products generally do not require pre-market approval or clearance, except for certain additives, they must comply with applicable labelling and promotional requirements and must not be manufactured in a manner that renders them adulterated (eg, contaminated). Such products must also be safe for human use. The U.S. Environmental Protection Agency (EPA) generally regulates biocides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), which requires, among other things, the registration of biocides and their manufacturing facilities. Depending on their intended use, however, biocides may also fall under FDA jurisdiction in certain instances.
1.3 New Products/Technologies and Digital Health
Certain digital health technologies, such as medical apps, telemedicine platforms, and wearables, may be subject to regulation under the FDCA if they meet the definition of a medical device as discussed in 1.1 Medical Devices. As a result of the passage of the 21st Century Cures Act in December 2016, the FDCA statutorily excludes software functions from the medical device definition, under 21 U.S.C. § 360j(o), that are intended:
- for administrative support of a healthcare facility;
- for maintaining or encouraging a healthy lifestyle and are unrelated to the diagnosis, cure, mitigation, prevention or treatment of a disease or condition;
- to serve as electronic patient records provided certain conditions are met;
- for transferring, storing, converting formats or displaying clinical laboratory test or other device data and results; or
- to serve as clinical decision support unless the function is intended to acquire, process, or analyse a medical image or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system and provided certain conditions are met.
In addition, the FDA is currently exercising enforcement discretion for certain software functions that may constitute medical devices as defined by the FDCA but are deemed by the FDA to be low risk. Specifically, the FDA is exercising enforcement discretion for software functions that help patients self-manage a disease or condition without providing specific treatment recommendations or treatment and software functions that automate simple tasks for healthcare providers. Manufacturers of these products are encouraged to seek guidance from the FDA through various administrative meeting and feedback mechanisms, such as the "pre-submission" meeting process and "request for classification" process.
1.4 Borderline Products
As a consequence of the broad definition of "medical device", many types of products fall within FDA jurisdiction. As noted, in some cases, the FDA has elected to exercise enforcement discretion. In others, fulfilment of FDA requirements, such as those governing manufacturing quality standards, may make reference to other regulatory or quasi-regulatory regimes. For example, while respirator particulate filtration claims are subject to the National Institute for Occupational Safety and Health and other non-FDA standards, these products are considered medical devices when marketed for a medical purpose, such as mitigation of airborne pathogens, and must go through the same registration, clearance, or approval pathway as other devices.
Originally published by Medical Devices & Consumer Health Products 2021 Guide, Chambers and Partners.
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