CDRH Report: The Barriers to Quality

A CDRH report says greater visibility on the agency’s expectations of device quality and properly aligning its regulatory approach are needed to improve device quality and reduce adverse events. The report, Understanding Barriers to Medical Device Quality, says FDA “should consider a comprehensive program centered on three parallel and overlapping agendas: (1) aligning compliance focus to address industry quality gaps; (2) enhancing transparency and visibility of performance to drive quality; and (3) increasing industry engagement.”

On transparency, the report says better quality can be achieved if more information about companies’ quality performance became available. It says FDA should “construct and routinely report industry-wide and product-category wide quality and patient outcome information,” along with publishing “a synthesis of causes and trends of adverse events and product recalls overall and by product class.”

Additionally, the report said for guidance, FDA could look to what agencies that regulate other technological indus-tries, like the Federal Aviation Administration and the Nuclear Regulatory Commission, are doing. The report says that “there exist opportunities to adopt best practices around how these agencies deal with the industry to promote and maintain a high level of safety and quality.”