The U.S. Food and Drug Administration (FDA) has issued a draft guidance regarding medical device submissions.
The document, "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program," explains how to request a meeting with the FDA regarding potential or planned medical device or device-led combination product submissions, the agency said.
When finalized, the guidance will replace the version issued in September 2017. The FDA is taking comments on the draft until August 6.
