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A sponsor of a device clinical trial or study that is not FDA-regulated and that does not meet the criteria for an applicable device clinical trial or study, and that begins on or after January 18, 2017, would be subject to the registration requirements of 21 CFR 312.94 if that clinical trial or study meets the criteria for an applicable device clinical trial or study, regardless of whether the clinical trial or study is registered or unregistered. (Note: 21 CFR 312.94 currently requires registration of a device clinical trial or study.
A clinical trial or study is an applicable clinical trial (ACT) under 42 CFR 11.10(a) if that clinical trial or study is a device clinical trial or study initiated on or after January 18, 2017, is FDA-regulated, and meets the requirements of 42 CFR 11.22(b). For a clinical trial or study that begins prior to January 18, 2017, but later than the effective date of the final rule and during the notice and comment period, the regulation provides additional rules. These additional rules are provided in 21 CFR 312.94.
A sponsor of a device clinical trial or study that is not FDA-regulated and that does not meet the criteria for an applicable device clinical trial or study, and that begins prior to January 18, 2017, would be subject to the registration requirements of 21 CFR 312.94.
At any point during this CTQP process, if an agency has knowledge of a deficiency in the application or information included in the CTQP checklist, the agency must notify the sponsor of such deficiency within 30 days.
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