The regulations in 42 CFR 11.22 require registration for applicable device clinical trials that were initiated after September 27, 2007. For those applicable device clinical trials that were initiated on or after January 18, 2017 that meet the conditions specified in 42 CFR 11.22(b)(1), the regulation requires the submission of registration information listed in 42 CFR 11.28(a)(2) for clinical trials and in 42 CFR 11.28(b) for pediatric postmarket surveillance of a device product that is not a clinical trial. 42 CFR 11.22(b)(1) describes the conditions for determining whether a clinical trial or study initiated on or after January 18, 2017 is an “applicable clinical device trial”. 42 CFR 11.10(a) explains that an applicable device clinical trial studies a device product “subject to section 510(k), 515, or 520(m) of the [FD&C Act]”. The Final Rule preamble further clarifies that a “device product is considered to be subject to section 510(k), 515, or 520(m) of the FD&C Act if any of the following is required before it may be legally marketed in the United States: (1) A finding of substantial equivalence under section 510(k) permitting the device product to be marketed, (2) an order under section 515 of the FD&C Act approving a pre-market approval application for the device product, or (3) an HDE [or Humanitarian Device Exemption] under section 520(m) of the FD&C Act” (81 FR 65012).
The determination of whether the study of a specific device product is an applicable device clinical trial does not depend on the product’s device classification in 21 CFR 860.3(c) (i.e., Class I, II, or III). The relevant question is whether the device product must receive a finding of substantial equivalence under section 510(k) of the FD&C Act, an order under section 515 of the FD&C Act approving a pre-market approval application for the device product, or an HDE under section 520(m) of the FD&C Act. Most Class I devices, but not all, 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 under section 515 of the FD&C Act. 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.
