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FDA communication policy

This article was originally published in The Gray Sheet

Executive Summary

510(k) sponsors can respond to FDA requests for further information via fax or e-mail without submitting a paper copy of the response, as long as it will not stop the review time "clock," according to FDA's policy on fax and e-mail communication with industry on premarket files under review. The policy, clarified in a March 1 1Blue Book memo allows for e-mail or fax to be used in response to requests related to PMAs, IDEs and other collaborative meetings, as long as the electronic response is followed by a paper copy. The memo, designed to promote the "least burdensome" provisions of FDAMA 1997, directs FDA reviewers to use e-mail or fax for information requests that do not stop the review clock...
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