Zdrowie i gospodarka · 13/08/2012

FDA Releases Draft Guidance for 510(k) Submissions

The Food and Drug Administration (FDA) has released a draft guidance document outlining the procedures for determining whether a premarket notification (510(k)) submission is complete and should be accepted for review. The document, titled 'Refuse to Accept Policy for 510(k)s,' applies to submissions reviewed by the FDA's Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER).