What is Not a Medical Device?
Understanding what falls outside the medical device definition is as important as understanding what falls within it.
Products excluded by definition
Drugs and biologics
Articles that achieve their primary intended purpose through chemical action within or on the body are drugs, not devices. Biologics (such as vaccines and blood products) are regulated separately under the Public Health Service Act.
Food and dietary supplements
Products regulated as food under 21 CFR Part 101 are not devices, even if they carry health claims. The boundary between a device and a food product is determined by mechanism of action, not by the nature of the claim.
Cosmetics
Under 21 U.S.C. § 321(i), cosmetics are articles intended to be rubbed, poured, sprinkled, or sprayed on the body for cleansing, beautifying, or altering appearance. A moisturiser with no medical claims is a cosmetic; the same product labelled to treat dermatitis may become a drug or a combination product.
General wellness products
FDA has issued guidance on General Wellness: Policy for Low Risk Devices (2019) establishing that certain low-risk general wellness products are not subject to FDA oversight as medical devices if they:
- are intended only for general wellness uses; and
- present a very low risk to the safety of users.
Examples FDA considers not devices under this policy:
- Exercise equipment (treadmills, weights) with general fitness claims
- Dietary tracking apps with no diagnostic intent
- Sleep monitoring wearables that report sleep duration but make no disease claims
However, if the labelling includes disease claims (e.g., "monitors atrial fibrillation"), the product crosses into device territory.
Key borderline areas
| Product type | Status | Basis |
|---|---|---|
| Blood pressure cuff (consumer) | Medical device | Diagnostic intended use |
| Smart watch — heart rate only | Generally not a device | General wellness |
| Smart watch — AFib detection | Medical device | Diagnostic claim |
| UV light — tanning | Not a device | Cosmetic intended use |
| UV light — psoriasis treatment | Medical device / radiation-emitting device | Therapeutic claim |
| Toothbrush (standard) | Not a device | Hygiene, no medical claim |
| Powered toothbrush claiming plaque removal | May be a device | Therapeutic dental claim |
How to determine your product's status
FDA's Product Classification Database (accessdata.fda.gov) is the starting point. If your product is not listed, consider:
- Submitting a Request for Designation (RFD) to FDA's Office of Combination Products (21 CFR Part 3).
- Requesting a pre-submission meeting with CDRH to discuss classification questions.
- Consulting the relevant product-specific guidance documents.