FDA Final Guidance Q-Submission Program

Today FDA issued a final guidance, “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.  Guidance for Industry and Food and Drug Administration Staff Document (May 7, 2019).  The FDA’s Q-Submission Program provides submitters an opportunity to have early collaboration and discussions about medical device submissions.

In our opinion, early feedback and interaction with FDA can be very valuable to ensure timely and successful submissions but with a caveat.  We recommend companies focus on grey areas or aspects open to interpretation, rather than routine aspects of submissions for their particular product and technology type. In addition, we suggest not asking open ended questions, but rather presenting approaches that the company prefers at least at first.  Then evaluate feedback from FDA and if what FDA suggests seems overly burdensome consider further interaction and rationale for alternate approaches.

Download the guidance at this link:  Requests for Feedback and Meetings for Medical Device Submissions-The Q-Submission Program-2019

You may be interested to also read our post of the recent De Novo submission guidance at this link:  FDA Final De Novo Submission Guidance

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.