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 can also be received as a formal, binding determination with an RFD.
But the “more flexible option” has become “increasingly customary with sponsors, and for some, even preferable to the formal RFD process,” according to the FDA. As such, the new guidance provides some clarifications and recommendations on the process used by FDA staff to review a Pre-RFD, the general timeframes for sponsors to receive feedback, the types of information that should be included in a Pre-RFD, and the process for sponsors to request a meeting with OCP.
The office intends to provide feedback on the two-part process — preliminary classification and jurisdictional asessment — within 60 calendar days or “communicate the need for more review time…in a timely manner.” Pre-RFDs should be clear and concise to receive timely reviews.
Sponsors are encouraged to “pay particular attention” to five sections of a Pre-RFD, which can be submitted at any point throughout a product’s development. These include the complete product description, its intended use; how it works; and any previously made or planned claims about the product. If it may be a combination product, the submission should also include any available information that relates to the “relative contribution of each of its components to the overall intended therapeutic/diagnostic effects of the combination product,” the agency said.
Considering a teleconference rather than an in-person meeting with OCP, and contacting the agency to present any additional information to the submitted Pre-RFD if a sponsor disagrees with the preliminary assessment are among the other recommendations in the guidance.
The submissions are not required of any sponsors, and are not needed for every product, as some already have well-established classifications and jurisdictional assignments. But for those that don’t, using this process to better understand how these products will be regulated by the FDA “will help lead to better decision-making for your company,” the FDA said.
Read the final guidance here: www.fdanews.com/02-15-18-PreRFDGuidance.pdf. — Ana Mulero