Dr. Bill Maisel to direct Center of Devices and Radiological Health

According to MedCity News, Dr. Bill Maisel has been selected to function as the deputy director of science for the Center of Devices and Radiological Health (CDRH) and chair the Center Science Council (CSC). The latter will be responsible for issuing the recall of devices in addition to setting standards for their approval. This is stirring up some controversy in the medical device industry.

In a statement written for the House Energy and Commerce health subcommittee last year, Maisel wrote last year, he stated:“[I]t is critical that the safety and performance of medical devices be improved, that the frequency of medical device malfunctions and adverse events be reduced, and that patients and physicians be adequately informed about device clinical effectiveness and risks in a timely fashion. In short, FDA needs to improve its science-based device assessments and decision-making."

What effects do you think this will have on the medical device industry?


This blog is c0-posted with the Future of Biopharma Blog.