Center for Devices and Radiological Health

The Center for Devices and Radiological Health (CDRH) recently issued strategic priorities for 2016-17.  The primary strategic priorities include:

  1.  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  • CDRH issued draft guidance describing how real-world evidence may be used to support pre- and post-market regulatory decisions.
  1. 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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