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The latest form for Draft Guidance for Industry; How to Prepare a Pre-Request for Designation (Pre-RFD) expires 2020-10-31 and can be found here.
Supporting Statement A
Approved without change
|New collection (Request for a new OMB Control Number)||2017-07-26|