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.