EMERGO SUMMARY OF KEY POINTS:

• New FDA guidance explains pre-request for designation (Pre-RFD) submission options specifically for combination product manufacturers.
• All Pre-RFD submissions for combination products and potential combination products go through the FDA’s Office of Combination Products (OCP).
• The Pre-RFD process is intended to address manufacturers’ questions regarding FDA classification and regulation.

The US Food and Drug Administration has issued new draft guidance clarifying the agency’s Pre-Request for Designation (Pre-RFD) process whereby combination product manufacturers may request initial feedback regarding classification and regulatory oversight questions.

The Pre-RFD program is also available for medical device, drug and other medical product manufacturers; the new draft guidance, however, focuses on how the FDA’s Office of Combination Products (OCP) provides feedback and responds to questions from combination product companies.

Most often, manufacturers seek OCP feedback regarding how their products will be regulated by the FDA—as medical devices, drugs or biological products. Firms may request formal and binding decisions from the OCP via full Requests for Designation, or opt for less formal feedback via the Pre-RFD process before undertaking premarket application efforts.

What to expect from a Pre-RFD

According to the guidance, a Pre-RFD entails a combination product manufacturer or sponsor submitting a written request to the OCP for a nonbinding and preliminary classification of its product as either a drug, device, biological product or combination product, and for a determination as to whether the product would be regulated by the FDA’s Center for Devices and Radiological Health (CDRH), Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER).

Pre-RFD submissions typically require less information than formal RFD submissions. The OCP usually takes a maximum of 60 calendar days to respond to Pre-RFD submissions.

What to include in a Pre-RFD for a combination product

The guidance lists information to include in a Pre-RFD, noting that the more data a manufacturer can provide, the better the OCP’s feedback will be.

Besides company contact information and product description, a Pre-RFD submitter should include the following:

• Any FDA 510(k), Premarket Authorization (PMA) or other regualtory submission number for the product in question
• Description of material processing methods (for products with biological materials)
• Description of how the product functions
• Product marketing plan—will component parts be co-marketed or sold separately and labeled for use together, for example
• List of product’s components and/or ingredients with explanations for their inclusion in the product
• Proposed, intended and indications for use statement
• Instructions for use
• List of all product’s methods and mechanisms of action
• Information describing relative contributions of different product components to overall intended effects
• List of all claims the manufacturer plans to make regarding the product