March 11, 2024
Individual products are determined to be medical devices based on the intended use of the product as described by the manufacturer. "Intended use" is a regulatory term meaning the purpose of the device or what you claim on your label that the device does. Indications for use are the circumstances or conditions under which the device will be used.
Per Section 201(h)(1) of the Food, Drug, and Cosmetic Act, a device is:
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
(A) recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
(B) 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
(C) 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.
CDRH defines general wellness products as products that meet the following two factors:
(1) are intended for only general wellness use, and
(2) present a low risk to the safety of users and other persons.
General wellness products may include exercise equipment, audio recordings, video games, software programs and other products that are commonly, though not exclusively, available from retail establishments (including online retailers and distributors that offer software to be directly downloaded), when consistent with the two factors above. A general wellness product, has:
1) an intended use that relates to maintaining or encouraging a general state of health or a healthy activity, or
2) an intended use that relates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.
The first category of general wellness intended uses involve claims about sustaining or offering general improvement to functions associated with a general state of health that do not make any reference to diseases or conditions. This first category of general wellness claims relate to:
weight management,
physical fitness, including products intended for recreational use,
relaxation or stress management,
mental acuity,
self-esteem (e.g., devices with a cosmetic function that make claims related only to self-esteem),
sleep management, or
sexual function.
The following are examples of this category of general wellness claims:
Claims to promote or maintain a healthy weight, encourage healthy eating, or assist with weight loss goals;
Claims to promote relaxation or manage stress;
Claims to increase, improve, or enhance the flow of qi “energy”;
Claims to improve mental acuity, instruction following, concentration, problem solving, multitasking, resource management, decision-making, logic, pattern recognition, or eye-hand coordination;
Claims to enhance learning capacity;
Claims to promote physical fitness, such as to help log, track, or trend exercise activity, measure aerobic fitness, improve physical fitness, develop or improve endurance, strength or coordination, or improve energy (e.g., “fitness” or “activity” trackers);
Claims to promote sleep management, such as to track sleep trends;
Claims to enhance an individual’s participation in recreational activities by monitoring the consequences of participating in such activities, such as to monitor heart rate or monitor frequency or impact of collisions.
The following are examples of claims that do not fall into this category of general wellness claims:
A claim that a product will treat or diagnose obesity;
A claim that a product will treat an eating disorder, such as anorexia;
A claim that a product helps treat an anxiety disorder;
A claim that a computer game will diagnose or treat autism;
A claim that a product will treat muscle atrophy or erectile dysfunction; and
A claim to restore a structure or function impaired due to a disease or condition, e.g., a claim that a prosthetic device enables amputees to walk.
The second category of general wellness intended uses relate to sustaining or offering general improvement to functions associated with a general state of health while making reference to diseases or conditions. This second category of general wellness claims is comprised of two subcategories:
1) intended uses to promote, track, and/or encourage choice(s), which, as part of a healthy lifestyle, may help to reduce the risk of certain chronic diseases or conditions; and
2) intended uses to promote, track, and/or encourage choice(s) which, as part of a healthy lifestyle, may help living well with certain chronic diseases or conditions.
The next item to consider is if the device would be considered low risk. Low risk to FDA means the following 3 questions can be answered no:
1) Is the product invasive?
2) Is the product implanted?
3) Does the product involve an intervention or technology that may pose a risk to the safety of users and other persons if specific regulatory controls are not applied, such as risks from lasers or radiation exposure?
If your claims are in line with the definition of a wellness product and meet the low risk requirements, FDA will consider your product as a low risk wellness product. In this case FDA, does not intend to examine low risk general wellness products within the meaning of the FD&C Act. They would not require premarket review or post-market regulatory requirements for devices and implementing regulations, including, but not limited to: registration and listing and premarket notification requirements (21 CFR Part 807); labeling requirements (21 CFR Part 801 and 21 CFR 809.10); good manufacturing practice requirements as set forth in the Quality System regulation (21 CFR Part 820); and Medical Device Reporting (MDR) requirements (21 CFR Part 803).
Quality System Establishment
Medical Device Manufacturers are required to comply with the Quality System Regulation (21 CFR 820). The FDA’s Quality System Regulation is parallel in content to the International Standards Organization ISO 13485: Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes. Just this month FDA published the Quality Management System Regulation which will harmonize 21 CFR 820 and ISO 13485 and include a more risk based approach to FDA quality system requirements. Compliance with the QSR (soon to be QMSR) is a requirement for medical devices to be sold in the United States. Compliance with ISO 13485 is a requirement for medical devices to be sold in the European Union, Canada, and other countries. Both documents cover design of devices, purchasing of components and contracted services, production, acceptance activities, distribution, and procedures for complaint handling, corrective actions, and recalls.
If you make medical device claims for your product that do not meet the wellness requirements, a quality system would be required.
Establishment Registration and Device Listing
Under 21 CFR Part 807, manufacturers of medical devices are required to annually register their establishments with FDA and provide a list of the devices they market, regardless of whether the product is exempt from needing a 510(k) submission. The registration and listing requirement is a means of keeping FDA advised of who is manufacturing devices, and of the types of devices an establishment is manufacturing. Manufacturers are required to register their establishments with FDA and to list by identifying to FDA the devices they are marketing.
If you make medical device claims for your product that do not meet the wellness requirements, FDA registration and listing would be required.
Adverse Event Reporting
The Medical Device Reporting (MDR) Regulation (21 CFR Part 803) requires manufacturers and importers of medical devices to submit reports to the FDA whenever they receive or otherwise become aware of information, from any source, that reasonably suggests that a device they market may have caused or contributed to a death or serious injury, or has malfunctioned and the device or a similar device that they market would be likely to cause or contribute to a reportable death or serious injury if the malfunction were to recur. MDR requires medical device manufacturers to Submit MDR-reportable events involving their medical devices as described in 21 CFR 803.10(c) and 803.50.
If you make medical device claims for your product that do not meet the wellness requirements, FDA adverse event reporting would be required.
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