Draft Guidance for Industry; How to Prepare a Pre-Request for Designation (Pre-RFD)

OMB 0910-0845

OMB 0910-0845

The ICR collects information from sponsors who wish to obtain a preliminary assessment (i.e., not legally binding) from the Agency regarding classification and primary jurisdiction of a medical product. Sponsors submit information as provided in Agency Pre-Request for Designation (Pre-RFD) Guidance regarding combination products, including description of the product, proposed use or indications, description of all known modes of action, etc. The information submitted is reviewed so that a preliminary classification and jurisdiction assessment can be made.

The latest form for Draft Guidance for Industry; How to Prepare a Pre-Request for Designation (Pre-RFD) expires 2020-10-31 and can be found here.

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