Is it a Drug, Device or Biologic? FDA Announces Changes to Request for Designation Program

In case you need a regulatory refresher, the Request for Designation is the formal process to determine which Center will conduct premarket review and regulate a combination product (See Guidance for Industry Office of Combination Products April 2011: How to Write a Request for Designation). Recently, FDA announced through FDAVoice that changes to the program are on the way. Included is a new “Pre-RFD” process that “may be preferable to the more formal RFD process when a sponsor would like to engage FDA using a more interactive approach”. Click here for help developing your combination product and here for the full story.

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