In Brief: FDA 510(k) fax policy
This article was originally published in The Gray Sheet
Executive SummaryFDA 510(k) fax policy: Beginning May 15, FDA will notify sponsors by fax as well as by mail whether a 510(k) is deemed "substantially equivalent" or "not substantially equivalent," provided a fax number is included with the premarket submission. The fax will be sent within one business day after the agency mails its decision, according to FDA staffers...
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