510(k) status inquiries by phone okay for complex resubmissions -- ODE's Alpert.
This article was originally published in The Gray Sheet
Executive Summary
510(k) STATUS PHONE INQUIRIES TO ODE are acceptable if a company is following up on the submission of extensive data made in response to an Office of Device Evaluation query, ODE Director Susan Alpert said at a May 6 Regulatory Affairs Professional Society conference in Rockville, Maryland. "If you got a very extensive response" from the agency "or the questions were to every issue in the 510(k), then I suggest you call the branch and find out what your time frame is," Alpert said. However, she added: "I don't encourage you to do it on everything that you submit. In fact, I discourage you from doing that."
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