Life Sciences

FDA explains when device certifications aren't necessary

Device Regulation Alert: Safety, Compliance and Reimbursement News, May 5, 2008

Draft FDA guidance will help device companies, sponsors, and FDA staff understand the obligation to complete certifications required by the Food and Drug Administration Amendments Act of 2007 (FDAAA).
 
The FDAAA added a new requirement for a certification that will provide additional information about relevant clinical trials. Section 402(j)(5)(B) to the Public Health Service Act mandates FDA Form 3674, OMB Control No. 0910-0616 be attached to some device applications and submissions. The certification provides more information to the public about clinical trials for the device and helps the FDA ensure compliance with various legal requirements. The certification requirement went into effect December 26, 2007.  
 
The FDA’s new guidance discusses the types of information and documents that do not need this certification. In deciding which types of submissions wouldn’t need a certification, the FDA considered what types of information and documents relate to or contain information about clinical trials. Submissions that don’t relate at all to clinical trials or relate to information about trials for which certifications were already submitted likely do not require a certification. Documents that do not require a certification fall into two categories:
  • Investigational applications and submissions
  • Marketing and post-marketing submissions  
For example investigational device exemption applications, amendments to investigational new drug applications, and IND safety reports would not require a certification, according to the FDA. Device-related marketing submissions that will not require a certification include humanitarian device exemptions and 510(k) submissions that don’t include clinical data.
 
The draft guidance only applies to the types of information and documentation referenced in the guidance. The FDA asks for comments about additional types of information and documents that shouldn’t need the certification attached. For comments to be considered before the final draft of the guidance issued, comments should be received by June 17. A public notice announcing the draft guidance and asking for comments was published in the April 18 Federal Register.

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