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PDP PROGRAM'S INCLUSION OF NOVEL TECHNOLOGIES REQUIRES BASIC PERFORMANCE DATA FROM SPONSORS, ALPERT SAYS; PANEL REVIEW OF PDPs WILL BE CONFIDENTIAL

This article was originally published in The Gray Sheet

Executive Summary

FDA intends to apply product development protocols to novel technologies, but wants product sponsors to provide enough data to allow the agency to commit to a study design, Susan Alpert, director of the Office of Device Evaluation in FDA's Center for Devices and Radiological Health, said at an Oct. 22 meeting in Washington, D.C. The PDP conference was sponsored by FDA and the Health Industry Manufacturers Association.
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