FDA Clarifies Certification Requirement

Apr 22, 2008
Untitled Document

Rockville, MD (Apr. 21)—The US Food and Drug Administration issued a draft guidance to clarify the agency’s intentions stated in the Food and Drug Administration Amendments Act of 2007 (FDAAA) requiring sponsors, industry, researchers, and investigators to complete certification form FDA 3674 when submitting documentation to the agency in order to comply with FDAAA, Title VIII.

FDA's Draft Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff was created in response to questions FDA has received about which documents and information should include the certification form. FDA states in the draft guidance that the agency “believe(s) that it would not further the purposes of the legislation if a certification were to accompany every type of information or document submitted to the agency regarding a medical product regulated by FDA.” The guidance goes on to state “FDA recommends that a certification typically need not accompany the types of submissions of information or documents to the agency listed below:

Investigational applications/submissions

  • Chemistry and manufacturing amendments to investigational new drug applications (INDs)
  • Nonclinical pharmacology/toxicology amendments to INDs
  • IND safety reports
  • Single patient INDs
  • Meeting requests
  • Investigational device exemption applications (IDEs)

Marketing and post-marketing applications/submissions

  • Chemistry and manufacturing amendments and supplements to biologics license applications (BLAs) and new drug applications (NDAs)
  • Nonclinical pharmacology/toxicology amendments and supplements to BLAs and NDAs
  • Humanitarian device exemptions (HDEs) and premarket approval application (PMA) 30 day notices
  • ANDA amendments and supplements that contain no in-vivo bioequivalence information
  • ANDA, BLA, and NDA promotional materials
  • BLA and NDA safety reports
  • ANDA, BLA, NDA, HDE, and PMA mandatory and voluntary adverse event or medical device reports
  • Meeting requests
  • 510(k)s that contain no clinical data.”

Click here to download the draft guidance.