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Certification to Accompany Drug, Biological Product, and Device Applications or Submissions

Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) amended the Public Health Service Act (PHS Act) by adding section 402(j) (42 U.S.C. 282(j)). The new provisions require additional information to be submitted to the clinical trials data bank (ClinicalTrials.gov), including expanded information on clinical trials and information on the results of clinical trials.

The agency has issued for comment a draft guidance, titled: “Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of The Public Health Service Act, Added By Title VIII of The Food and Drug Administration Amendments Act of 2007”. According to the draft guidance, some device applications and submissions to the FDA that are not related to clinical trials may not need the certification form. Anyone wishing to comment on the draft guidance is requested to submit electronic or written comments within 60 days.

Links:

The following links may be helpful:

• Link to the draft guidance
  http://www.fda.gov/oc/initiatives/fdaaa/guidance_certifications.html
   
• Link to the published Federal Register Notice:
  http://www.fda.gov/OHRMS/DOCKETS/98fr/07-6023.htm (txt)
  http://www.fda.gov/OHRMS/DOCKETS/98fr/07-6023.pdf (pdf)
   
• Link to the certification form:
  http://www.fda.gov/opacom/morechoices/fdaforms/FDA-3674.pdf
   
• Link to FDAAA, Public Law 110-85:
  http://www.fda.gov/oc/initiatives/HR3580.pdf

Updated June 20, 2008

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