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- CDRH issued draft guidance describing how real-world evidence may be used to support pre- and post-market regulatory decisions.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