New FDA form
This article was originally published in The Gray Sheet
Agency is expediting creation of a form that device and drug firms must use to certify compliance with new clinical trial registration requirements accompanying premarket submissions to the agency. Companies will need to begin registering trials for certain products with ClinicalTrials.gov beginning Dec. 26 under the requirements of the FDA Amendments Act, and firms must certify that they have done so for all PMA, 510(k) and humanitarian device exemption submissions
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