New FAQs on 42 CFR Part 11 Requirements: The Frequently Asked Questions (FAQs) page has been updated with four new FAQs:
- Are “pilot” drug or device studies considered to be an “applicable drug clinical trial” or “applicable device clinical trial,” respectively, under the regulation?
- When are results due for an applicable clinical trial (ACT), if a certification of delay for an approved, licensed, or cleared product (“certify new use”) has been submitted under 42 CFR 11.44(b)?
- Are appendices required to be included in the uploaded study protocol?
- When does my obligation to update clinical trial information end?