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.
One new FDAAA provision, 42 U.S.C. 282(j)(5)(B), requires that a certification (see form below) accompany human drug, biological, and device product submissions made to FDA. At the time of submission of an application under sections 505, 515, or 520(m) of the FD&C Act (21 U.S.C. 355, 360e, or 360j(m)), or under section 351 of the PHS Act (21 U.S.C. 262), or submission of a report under section 510(k) of the FD&C Act (21 U.S.C. 360(k)), such application or submission must be accompanied by a certification that all applicable requirements of section 402(j) of the PHS Act have been met. For the Center of Devices and Radiological Health, premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, and premarket notifications (510(k)) require certification. Where available, such certification must include the appropriate National Clinical Trial (NCT) numbers.
FDAAA requires that the certifications be submitted to FDA beginning no later than December 26, 2007.
The agency has issued for comment a draft guidance, titled: “Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of The Public Health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 According to the draft guidance, some device applications and submissions to the FDA that are not related to clinical trials may not need the certification form. Anyone wishing to comment on the draft guidance is requested to submit electronic or written comments within 60 days.
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Updated May 2, 2008
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