Tip of the Week Archive

Under the Oversight module in the Protocol section, you’ll need to answer whether the trial studies a U.S. FDA-regulated Device by selecting “Yes” or “No”. So, what qualifies as a U.S. FDA-regulated Device?

ClinicalTrials.gov defines this field as indicating whether “a clinical study is studying a device product subject to section 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act.” Let’s explore that a little further.

Contrary to what you might expect, whether you should answer “Yes” or “No” doesn’t directly depend on the device classification* (i.e., Class I, II, or III). ClinicalTrials.gov defines “FDA regulated device” as a device that must receive:

1. a finding of substantial equivalence under section 510(k) of the FD&C Act,
2. an order under section 515 of the FD&C Act approving a pre-market approval application for the device product, or
3. a Humanitarian Device Exemption under section 520(m) of the FD&C Act.

Most Class I devices and some Class II devices are exempt from the requirements for a finding of substantial equivalence under section 510(k) of the FD&C Act and do not require a premarket approval order. By contrast, most Class II and all Class III devices require either clearance under section 510(k) of the FD&C Act or premarket approval under section 515 of the FD&C Act.

*in 21 CFR 860.3(c)