Not All Device, Drug and Biologic Submissions Need Certification

Some device, drug and biological product applications and submissions to the FDA that are not related to clinical trials may not need the certification specified in the Food and Drug Administration Amendments Act of 2007 (FDAAA), the agency says in a draft guidance.

In the draft, the agency says it has received many questions about the types of information and documents that must be accompanied by the certification. The draft explains that the purpose of Title VIII of FDAAA is to ensure public access to information about ongoing clinical trials and their results.

The certification requirement helps achieve that goal by having study sponsors and others confirm that they have “complied with all applicable requirements of Title VIII, including the requirement to register applicable clinical trials,” the FDA says.
 
The draft lists types of submissions and applications unrelated to clinical trials that typically do not need certification:

The draft can be viewed at www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0224-GDL.pdf.