In a March 19 webinar, the FDA amplified its commitment to exercising discretion when devicemakers seek waivers for new requirements that aim to support quality and integrity of clinical data and protection of human subjects by incorporating good clinical practice (GCP) standards.
A final rule on human subject protection, which went into effect on effect Feb. 21, requires that data from medical device trials be gathered in accordance with GPCs. It applies to data that supports investigational drug exemption applications, 510(k) submissions, and de novo classification requests, as well as applications for premarket approval, product development protocols and humanitarian device exemptions. It also applies to bench and in vitro diagnostic studies of de-identified specimens.
The final rule aligns with the FDA’s vision that patients deserve access to high quality, safe and effective devices, said John Doucet, lead reviewer at FDA’s Office of Device Evaluation. But the agency also recognizes that companies are conducting more multi-national investigations and often rely on foreign clinical data.
In the webinar on implementation of the final rule, the agency said it may grant waivers in cases where informed consent is impossible to approve, such as for research on leftover human specimens and where sharing subject medical data is prohibited by local laws.
To improve chances for FDA approval of a noncompliant application, companies should outline steps researchers took or will take to ensure credible, accurate data and to ensure human subjects are adequately protected, said co-presenter Dina Stolman, a consultant and past medical officer in FDA’s Center for Biologics Evaluation and Research. Applicants should include a cover letter clearly stating the waiver request, she added.
It’s good practice to communicate with the review team before going into the pre-market submission phase, but it’s not mandatory, Stolman said. “You can come in with a reason for noncompliance and that [can be] an acceptable reason.”
Companies can also request a waiver before beginning a study.
The agency issued a guidance in 2018 outlining how to meet the agency’s requirements, request waivers and provide the required information to support clinical data submissions.
Read the guidance here: house link: www.fdanews.com/03-28-19-GCPGuidance.pdf.
Read the final rule here: house link: www.fdanews.com/03-28-19-GCPFinalRule.pdf. — Gienna Shaw