At the Advanced Medical Technology Association (AdvaMed) conference held in Chicago in October, several FDA officials participated in panel discussions and Dr. Margaret A. Hamburg, FDA Commissioner, was a plenary luncheon speaker for an in-depth discussion of how FDA policies are affecting the industry. FDA Commissioner since 2009, Hamburg revealed that the FDA is working on ways to get new products to market faster in a more collaborative manner now than at any time in its history.

One part of the FDA’s new action plan for 2015 concerns jointly developing new inspection approaches and training. The Center for Devices and Radiological Health (CDRH) and Office of Regulatory Affairs (ORA), for example, will start focusing some inspections on characteristics and features of medical devices most critical to patient safety and device effectiveness, including an expedited approval process for devices aimed at treating life-threatening or irreversibly debilitating diseases or conditions for which there are no other products available, Hamburg explained.

However, “this is a work in progress,” Hamburg said. “We all know that change does not happen overnight.... We still have some challenges in being able to recruit and retain all the people we need” [to review products].

She, and other speakers, explained that there may be up to a three year gap from when products are approved in other countries and when they can be launched in the US. It may seem easier to get a CE Mark approval, but Hamburg cautioned attendees to not view Europe as a regulatory model, since she explained that safety concerns have “prompted a reassessment of review processes”. “It’s not really a race as to who’s first,” she said. The real goal is “to get great products to individuals.”

Dr. Steven Solomon, ORA Deputy Associate Commissioner, and Dr. Steven Silverman, Director, Office of Compliance, CDRH, were part of an FDA/Industry Case for Quality Committee that spent the past three-and-a-half years meeting to discuss ways to improve product safety and quality at a lower total quality cost. This Case for Quality Committee has developed a Library of Successful Quality Practices for Medical Devices, hosted on the AdvaMed website, and can be accessed here .

It is intended as a resource for industry, to serve as a toolkit for companies to improve their quality systems and product safety using proven methods and current practices already employed by companies in the medical device industry. Its benefits include a disciplined approach to improving cost of quality, speed to market, and communicating with and engaging engineering design teams at the earliest stages.

Beth G. Sisk

Editor


Topics:
Medical