Medical devices and consumer health products 2021: Trends and developments – Food, drugs, healthcare, life sciences
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1. APPLICABLE PRODUCT SAFETY REGIMES
1.1 Medical devices
The Federal Food, Drug, and Cosmetic Act (FDCA) and the Public Health Service Act (PHSA) are the two key laws governing the development, manufacture, distribution, registration, licensing, authorization and approval of these products in the United States. The United States Food and Drug Administration (FDA) is the federal administrative agency with primary authority to ensure that these products are safe and effective for their intended uses by applying FDCA. The FDA issues regulations and guidance documents that further detail and interpret the requirements of the FDCA. The relevant regulations are found in Title 21 of the United States Code of Federal Regulations.
The Federal Trade Commission (FTC) is the primary federal agency responsible for monitoring unfair, deceptive and anti-competitive advertising, as well as other business practices, including in the medical products industry. Through a Memorandum of Understanding, and as discussed below, the FDA and FTC share jurisdiction over the regulation of medical devices and certain other medical products. The main statutory authority of the FTC is the United States Federal Trade Commission Act, which, among other things, prohibits unfair or misleading advertising. Many states have implemented their own similar consumer protection / unfair or misleading advertising laws. Additionally, many states have laws regulating the manufacture 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)”. The intended use of a product refers to “the objective intention of those legally responsible for labeling the devices”; see 21 CFR § 801.4. Such objective intention can be demonstrated by, inter alia:
- labeling of claims;
- oral or written statements by a manufacturer or its representatives; and
- circumstances surrounding the distribution of a product.
The FDCA defines a “device” as meaning, in the relevant part, an “instrument, apparatus, tool, machine, artifice, reactive in vitro implant 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, alleviation, treatment or prevention of disease, in humans 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 main purposes by chemical action inside or on the body of man or other animals and which does not depend on being metabolized for its primary purposes “; see 21 USC § 321 (h).
When a product falls within the scope of this legal definition, the FDA may regulate that product as a medical device under the FDCA. In some cases, the FDA has the power to exercise “discretion” – that is, the power not to apply some or all of the requirements of the FDCA to manufacturers of products that meet the definition of. a medical device but which, according to the FDA, presents a low risk of harm. to patients, either because of regulation via a parallel or complementary regulatory regime (as in the case of certain in vitro diagnostic tests) or because of the inherent properties of the product (such as clinical decision support software that uses (understand entrances and exits to help a physician track a patient’s disease symptoms).
The FDA applies a risk-based classification to its regulation of medical devices. This means that the classification of a particular device dictates the requirements for its development, manufacture and marketing. The FDA classifies devices into three classes based on their risk.
Class I devices present the lowest level of risk and are those for which general controls (i.e. basic FDA device authorities) are sufficient to provide reasonable assurance of safety and reliability. effectiveness of these devices.
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 the safety and effectiveness of such devices, and for which there is sufficient information to establish special controls (i.e., additional FDA authorities for devices, including performance standards) to provide such assurance.
Class III devices present the highest level of risk and are those which support or maintain human life, are of substantial importance in the prevention of harm to human health, or which present an unreasonable potential risk of disease or of injury.
1.2 Health products
The FDA also regulates cosmetics and foods, including dietary supplements, under the FDCA. Although these products generally do not require pre-market approval or authorization, with the exception of certain additives, they must comply with applicable labeling and promotion requirements and must not be manufactured in a manner that makes them adulterated (eg contaminated). These products must also be safe for humans. The United States Environmental Protection Agency (EPA) generally regulates biocides under the Federal Insecticides, Fungicides, and Rodenticides Act (FIFRA), which requires, among other things, the registration of biocides and their facilities. Manufacturing. Depending on their intended use, however, biocides may also fall under the jurisdiction of the FDA in some cases.
1.3 New products / technologies and digital health
Certain digital health technologies, such as medical applications, telemedicine platforms, and wearable devices, may be subject to regulation under the FDCA if they meet the definition of a medical device as set out in 1.1 Medical devices. Following the passage of the 21st Century Cures Act in December 2016, the FDCA statutorily excludes software functions from the definition of medical devices, under 21 USC § 360j (o), which are intended to:
- for the administrative support of a health establishment;
- to maintain or encourage a healthy lifestyle and are not related to the diagnosis, cure, mitigation, prevention or treatment of any disease or condition;
- serve as an electronic patient record provided certain conditions are met;
- to transfer, store, convert formats or display clinical laboratory tests or other device data and results; Where
- serve as a clinical decision aid, unless the function is intended to acquire, process or analyze a medical image or a signal from an in vitro diagnostic device or a model or a signal from a signal acquisition system and provided that certain conditions are met.
In addition, the FDA currently exercises enforcement discretion for certain software functions that may constitute medical devices as defined by the FDCA but which are considered by the FDA to be low risk. Specifically, the FDA exercises enforcement discretion for software functions that help patients manage a disease or condition on their own without providing specific treatment recommendations or treatment and software functions that automate simple tasks. for health care providers. Manufacturers of these products are encouraged to seek advice from the FDA through various administrative meeting and feedback mechanisms, such as the “pre-submission” meeting process and the “request for classification” process. .
1.4 Limit products
Due to the broad definition of “medical device,” many types of products fall under the jurisdiction of the FDA. As noted, in some instances the FDA has chosen to exercise enforcement discretion. In others, meeting FDA requirements, such as those governing manufacturing quality standards, may refer to other regulatory or quasi-regulatory regimes. For example, although respirator particulate filtration claims are subject to the National Institute for Occupational Safety and Health and other non-FDA compliant standards, these products are considered medical devices. when marketed for medical purposes, such as airborne pathogen mitigation, and must go through the same registration, authorization or approval process as other devices.
Originally posted by Medical devices and consumer health products Guide 2021, chambers and partners.
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