FDA medical device classes
also: Class I · Class II · Class III · 510(k) · PMA · De Novo
The US risk classes for medical devices: Class I is lowest risk, most Class II need 510(k) clearance, Class III generally needs premarket approval.
A product intended to diagnose, treat, mitigate or prevent disease, or to affect the structure or function of the body, may be a medical device regulated by the FDA. Class I (low risk) devices are mostly exempt from premarket review but still subject to general controls. Most Class II devices need a 510(k) showing substantial equivalence to a legally marketed device. Class III (highest risk) devices generally need premarket approval (PMA). The De Novo pathway covers novel low-to-moderate-risk devices.
Intended use, shaped largely by your marketing claims, drives classification: the same hardware can be a wellness product or a regulated device depending on what you say it does. The FDA has published guidance on general wellness products and on device software functions.
Medical devices also bring quality-system, design-control and cybersecurity documentation requirements that are best planned from the start.
Founder takeaway
Before writing marketing copy, check whether your claims would make the product a medical device, and get regulatory advice early if they might.
engineer review pending