FDA Reconsiders UDI Direct Marking Requirements For Implants
This article was originally published in The Gray Sheet
An agency official says FDA is reworking the UDI direct part marking requirements for implants and making other changes in the final unique device identification rule, due out in June.
You may also be interested in...
The long-awaited unique device identifier final rule is intended to help FDA, device companies and health care providers track medical devices. The rule addresses many of industry’s concerns with FDA’s initial proposal and was met with general support by companies.
Funds for FDA’s Mini-Sentinel post-market surveillance program were originally capped at $100 million based on projections for a consortium of at least three automated health care data partners to build analysis capabilities for data covering 100 million patients. The project has significantly exceeded those goals.
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.