Business · 02/01/2013

FDA Releases Guidance on 510(k) Refuse to Accept Policy for Medical Device Submissions

The Food and Drug Administration (FDA) has made available a new guidance document outlining the procedures and criteria for determining whether a 510(k) submission is complete and eligible for substantive review and clearance, affecting medical device submissions reviewed by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER).