The US Food and Drug Administration (FDA) on Wednesday issued a new draft guidance giving device makers an overview of the types of feedback and meetings they can request during pre-submission phase as part of the agency’s Q-submission program.
The draft guidance is meant to update and replace the agency’s recently finalized Requests for Feedback on Medical Device Submission: The Pre-Submission Program and Meetings with Food and Drug Administration Staff to account for changes made under the Medical Device User Fee Amendments of 2017 (MDUFA IV).
FDA also says the guidance provides a number of general clarifications regarding the Q-submission program.
Under the MDUFA IV negotiations, FDA and industry agreed to a number of changes to the Q-submission program, including how meetings are scheduled and establishing a performance goal for the timing of FDA feedback to device makers on pre-submissions.
Specifically, FDA committed to respond to pre-submissions within 15 calendar days to inform the applicant whether the application has been accepted, and if so when the requested meeting or teleconference will take place. FDA also agreed to provide written feedback on the issues raised in pre-submission requests for a minimum number of pre-submissions for each year of the MDUFA IV program.
FDA says the guidance applies to a host of device-related submissions, including potential or planned applications for investigational device exemption (IDE), premarket application, humanitarian device exemption, de novo requests and 510(k) submissions. The guidance also applies to pre-submission feedback and meetings for Clinical Laboratory Improvement Amendments waivers by application, device accessory classification requests and certain investigational new drug and biologics license applications.