USA – CDRH official offers advice for smoother Q-submission meetings

A policy analyst with the US Food and Drug Administration (FDA) walked through mechanisms the medical device industry can use to request pre-submission meetings, as well as best practices for ensuring smooth reviews.

Susannah Gilbert, Q-submission program lead with the division of regulatory programs at FDA’s Center for Devices and Radiological Health (CDRH), gave the updates at a 21 July webinar sponsored by the FDA’s Small Business Regulatory Education for Industry (REdI).

Gilbert described the three common types of Q-submissions used by manufacturers, and how they differ. These review mechanisms were outlined in FDA’s final guidance on Q-submissions, but the agency still fields questions about the various Q-submission types, she said. (RELATED: FDA Finalizes Q-Submission Feedback and Meetings Guidance, Regulatory Focus, 6 May 2019)…