Who is Les Weinstein?
BY LAUREN UZDIENSKI, JUNE 21, 2006
You may not know his name, but Les Weinstein plays a crucial role at the Center for Devices and Radiological Health (CDRH). Appointed in 2000 as the agency's first Ombudsman, he is an external voice of neutrality in disputes between industry and the CDRH. Throughout his tenure, Weinstein has advocated communication and cooperation between the agency and industry, supporting quality controls that strive to prevent complaints and a clear process for resolving those that do arise.
At last week's MDMA Annual Meeting, CDRH Director Daniel Schultz alluded to Weinstein's role in a discussion of appealing an FDA report. Weinstein is the go-to contact for industry, consumer, and health care provider complaints, of which industry firms initiate 75%. Consumer and provider issues comprise the remaining quarter of all cases. Complaints and disputes are most often sourced to miscommunication, lack of communication or data and testing requirements to support 510K submissions, but they can range from safety issues to grievances about agency employees. The Ombudsman provides effective, impartial recourse and mediation: at the end of 2005, a third of the year's cases were resolved, and another 41% were pending. The percentage of cases resolved has increased steadily since 2002, as charted in the Ombudsman's 2005 report.
In addition to Ombudsman, Weinstein carries the title of Quality Assurance Manager. He calls the dual roles "two sides of the same coin," with the latter reflecting a focus on maintaining the quality and efficiency of CDRH decisions.
One of the values on which Weinstein has built his office is communication, from his own role as a listener and mediator to his interaction with the industry. Further to his commitment to being an accessible contact for device manufacturers, Weinstein speaks frequently at trade events and meets with firms to get a sense for their concerns. In a recent interview with Medical Device Daily, Weinstein discussed his interaction with both established firms and emerging companies who may be coming to the FDA for the first time. "I view my role," he says, "as helping them through the process."
