FDA Promises Details on Electronic Submission Formats

Under the FDA’s MDUFA IV commitments, the agency is developing electronic submission templates for device sponsors, but it says it’s “not feasible to describe and implement the electronic formats that would apply to all submissions in a single guidance,” in a draft guidance released last week.

Electronic submissions will be required for 510(k) premarket notifications, De Novo designations, premarket approval applications, product development protocols, humanitarian device exemptions, emergency use authorizations, and certain investigational new drug and biologics license application. The agency plans to issue separate draft guidances to specify formats for different types of submissions. Once finalized they will be binding, the agency says.

Read the draft guidance here: www.fdanews.com/09-27-19-eSubmissionParentGuidance.pdf.