FDA Looks for Data-Mining Tool to Spot Adverse Drug Reactions

Agency also extends response period for proposals to develop medical device registries.

The Food and Drug Administration is giving contractors an extra week to submit proposals for helping the agency develop national and international medical device registries.

The FDA has a dozen device registries, but its request for proposal notes that impracticality of developing new registries as the types of register-eligible medical devices continue to expand. The RFP was issued July 31 with a response deadline of Aug. 15. On Thursday the FDA extended the deadline to Aug. 24.

The goals are to:

  • Establish an approach and framework for developing and maintaining medical device registries and groups of registries for a National Medical Device Postmarket Surveillance System.
  • Solicit best-practices suggestions.
  • Promote strategic planning that results in a robust post-market surveillance structure.

The winner of the one-year contract will organize and manage a series of workshops leading to a roadmap for developing the registries. The workshops will cover governance, structure and sustainable business models; utilization of electronic health-care data; strategic planning, including integration with electronic health records; registry use in regulated studies, including FDA pre- and post-market studies; communication of findings in registries; and identifying device groups needing registries and whether registries should be created for non-implantable devices.

The FDA wants to hold the first workshop by the end of September.

The agency also requested proposals this week for a data-mining tool to spot adverse drug reactions. Responses for the RFP, issued Wednesday and updated today, are due Aug. 24.

The proposal seeks support for data-mining and pattern-recognition technology to predict as-yet-unrecognized safety signals for new drug candidates, and to evaluate know safety signals for drugs already on the market.