Industry News

Final Pre-Submission Guidance Issued by FDA

In FDA, Industry Reposts, Regulatory by Anney Majewski

FDA issued the final pre-submission guidance, “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff”, on February 18th of this year. The guidance is set to help the reader determine when a pre-submission is beneficial or unnecessary.

A webinar was held by FDA on the 26th of February to discuss the types of requests covered by the final guidance, and the key provisions. Some of the new changes include the logging of meeting minutes as a formal amendment to be reviewed and edited by FDA and a Q-Sub Acceptance Checklist. Along with the Q-Sub Acceptance Checklist, FDA intends to perform an “Acceptance Review” corresponding to the feedback timeframe listed in the guidance. The Acceptance Review in the final guidance does not include a list of required elements in order for a Q-Sub to be accepted, differentiating it from the 510(k) and PMA Refuse to Accept (RTA) Policies.

For further information, read FDA issues final guidance on the medical device pre-submission program.

For questions regarding NAMSA and the Final Pre-Submission Guidance, please reach out to us at namsa.com/contact-us.

Authors:

Anney Majewski is the Marketing Communications Specialist at NAMSA, focusing on expanding the overall knowledge and understanding in the medical device industry. She obtained a BBA in Marketing from the University of Toledo as well as an A.S. in Psychology from Monroe County Community College.