FDA Clarifies Process to Obtain Informal Feedback Prior to Marketing Submissions

The FDA used a Q&A format to issue final guidance on an informal, non-binding process for sponsors to obtain preliminary feedback before submitting marketing applications.

Sponsors of medical products have the option of obtaining preliminary assessments using the Pre-Request for Designation (Pre-RFD) process — available through the Office of Combination Products (OCP) — with regard to the “regulatory identity or classification of a human medical product as a drug, device, biological product, or combination product,” the FDA said.

The process also lets sponsors know which center within the FDA — CDER, CDRH, or CBER — will regulate a non-combination product, or will have the primary jurisdiction over the premarket review and regulation of a combination product. Information on both the product classification and appropriate center also can also be received as a formal, binding determination with an RFD.