During a routine monitoring visit of a physician-sponsored IDE study, it was noted that the site was receiving “waivers” from the Sponsor to enroll subjects who did not meet one of the anatomical exclusion criteria. A
From the FDA’s perspective, did the Sponsor do enough?
I contacted the FDA at the email address where they accept and answer questions to ask them this very question. (firstname.lastname@example.org) I received the following prompt response from Soma Kalb,
FDA expects that deviations from a study protocol should be rare and that investigators and sponsors should exercise due diligence in avoiding them. Please refer to FDA Guidance “Design Considerations for Pivotal Clinical Investigations of Medical Devices” (2013), Section 9.2 Study Conduct - http://1.usa.gov/1PLPZBl
Study deviations that are “eligible for reporting in the IDE annual report are those that would not affect: a) the validity of the data or information resulting from the completion of the approved
In rare circumstances, there may be a reason to plan a deviation from the protocol. When a deviation is planned ahead of time, such as when a subject is proposed to be enrolled as part of the study cohort even though they do not meet the enrollment criteria, and the sponsor agrees
The takeaway message from the FDA is that the Sponsor should have submitted and received approval from the FDA for the planned protocol deviations. Reporting the deviations via the APR was good, but doesn’t protect them from being cited for those deviations in the event of an FDA audit.202/365: Making a Phone Call via