The Center for Devices and Radiological Health (CDRH) recently issued strategic priorities for 2016-17. The primary strategic priorities include:
- Establish a National Evaluation System for Medical Devices (NEST), to efficiently harness real-world “evidence of clinical experience.” Actions taken to date include, among others:
- A multi-stakeholder Planning Board and the Medical Device Registry Task Force issued a series of reports that outline the organizational structure and infrastructure for the NEST Coordinating Center, in February 2015, April 2016, August 2015, and September 2016.
- The FDA awarded $3 million the Medical Device Innovation Consortium (MDIC) and $1 million to other organizations toward this goal in 2016.
- CDRH issued draft guidance describing how real-world evidence may be used to support pre- and post-market regulatory decisions.
- Partner with patients, and work together to advance development and evaluation of innovative devices, and monitor performance of marketed devices. Actions taken to date include, among others:
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