The US Food and Drug Administration (FDA) on Monday finalized guidance providing medical device makers with an overview of the types of feedback and meetings they can request related to various submissions as part of the agency’s Q-submission program.
The guidance finalizes a draft version
released for comment in June 2018 and supersedes the agency’s 2017 guidance
on requests for feedback on medical device submissions and reflects changes to the Q-submission program under the Medical Device User Fee Amendments of 2017
FDA has also announced it will host a webinar
on 11 June 2019 at 3:00 PM EST to discuss the guidance.
Specifically, the guidance discusses the different mechanisms available to device makers for requesting feedback or a meeting with FDA staff during the presubmission phase for investigational device exemption (IDE) applications, premarket approval applications (PMAs), humanitarian device exemption (HDE) applications, de novo
requests, premarket notification (510(k)) submissions, Clinical Laboratory Improvement Amendments
(CLIA) waivers, dual (510(k)) and CLIA waiver by application submissions, accessory classification requests and certain investigational new drug (IND) applications and biologics license applications (BLAs).
While the guidance has been updated from the draft version for clarity and to include references to guidances issued since the draft version was released, the recommendations and details about the Q-submission program are largely the same.
In one change from the draft version, FDA has removed one of the other uses of the Q-submission program listed that discussed using informational Q-submission meetings to discuss requesting a waiver for requirements under 21 CFR 812.28, which details requirements for FDA to accept data from clinical investigations conducted outside the US.
The final guidance also includes a new table in the section on processes by Q-submission types that details the corresponding method of feedback and timeframes for pre-submission, submission issue request (SIR) and information meeting Q-submissions.
Additionally, FDA has expanded the second appendix to include cybersecurity as a topic for pre-submission questions, with four questions included as examples of cybersecurity questions that could be addressed via Q-submission feedback.
, Federal Register Notice