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  • CDRH issued draft guidance describing how real-world evidence may be used to support pre- and post-market regulatory decisions.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:
  • CDRH chartered and began recruiting members for a new FDA Patient Engagement Advisory Committee (PEAC), to discuss high priority topics relating to patient input in the total product lifecycle.
  • CDRH trained staff members on patient reported outcomes (PRO) and patient preference information (PPI) to advance staff understanding and CDRH review capacity in these areas.
  1. Promote a culture among manufacturers and at CDRH of quality and organizational excellence, with the goal of increasing the ability to design and make devices that are high-quality, safe and effective, and to increase CDRH’s ability to provide the necessary oversight. Actions taken to date include, among others:
  • CDRH completed a document control system, designed to ensure that key documentation is available to staff (including standard operating procedures, work instructions, forms, templates and process maps).
  • CDRH became a member or the American Society for Quality (ASQ), providing FDA employees with access to ASQ learning resources, and offered on-site quality training which resulted in more than 90 percent of participants receiving ASQ quality certification.
  • Partnered with MDIC to collect input from stakeholder forums; developed metrics and best practices designed to assess quality system performance using pre-production, production and post-production data; and led development of a product quality dashboard to assist hospital value analysis committees in identifying high quality devices.
  • CDRH continued its partnership with MDIC, CMMI Institute and other stakeholders to expand the application of the maturity appraisal process with the goal of developing the framework for a voluntary program in 2017.

This post was co-authored by Valeriya Svystun, legal intern at Robinson+Cole. Valeriya is not yet admitted to practice law.