CDRH Seeks To Expand Public-Private Medical Device Epidemiology Network
This article was originally published in The Gray Sheet
FDA hopes the MDEpiNet post-market surveillance program will be fully functional by the end of the year. A May public meeting is planned to catalyze the effort.
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The man who coined the term “Unique Device Identification,” Jay Crowley, opens up in an interview about hurdles FDA faced in setting up the system; anxiety he felt when Congress set a deadline for the final rule to be published; and why he believes UDI would have eventually happened organically anyway, among other UDI-related topics. “Sometimes people call me Mr. UDI … I think that name might stick for a while,” jokes Crowley, who planted seeds in 2002 for FDA’s new regulation to track and trace products. Since then it has mushroomed into an emerging program that has the backing of a majority in industry.
CDRH Director Jeffrey Shuren told participants at the AdvaMed annual meeting to expect early feasibility studies final guidance very soon and a guidance on 3D printing within two years. The center also announced updates on its national post-market surveillance plan and 510(k) refuse-to-accept policy programs, among other matters.
The device center released an updated plan for post-market surveillance reforms, featuring a planning board that will establish a governing structure for the new system, as well as implementation dates for various post-market projects.