FDA issues proposal to strengthen post-market med device surveillance

The U.S. Food and Drug Administration recommends strengthening post-market medical device surveillance in a new report released this month. Among the changes called for by the FDA are:

  • Establishing a unique device identification (UDI) system and promoting its incorporation into electronic health information.
  • Promoting development of national and international device registries for select products and integrating those registries into electronic health records.
  • Modernizing reporting and analysis of adverse events.
  • Developing new methods for generating, synthesizing and evaluating evidence.

"It bears emphasizing that modernizing medical device post-market surveillance is a long-term effort," FDA officials said in the report, "Strengthening our National System for Medical Device Postmarket Surveillance." "Our proposed strategic changes are intended to complement our existing programs."

The FDA is inviting feedback on the proposal through its website and meetings to be held later this month.

In July, the FDA issued a proposed rule to place unique device identifiers on medical devices, which aids in post-market surveillance by facilitating the reporting of adverse events. The FDA has been testing UDIs since 2009.

Congress also has pushed for UDIs, with the Senate introducing legislation last spring requiring the U.S. Department of Health & Human Services to issue a final rule on UDIs by the end of this year.

To learn more:
- read the report (.pdf)
- see the proposed UDI rule

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