The FDA’s med tech priorities – and what they mean for entrepreneurs
At the MedTech Investing Conference in Minneapolis on Wednesday, Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health outlined the administration’s key priorities related to the med tech industry. In a live video interview with Mark Leahey, president of the Medical Device Manufacturers Association, Shuren discussed the FDA’s ongoing efforts to provide U.S. patients with access to safe, quality medical devices. “Many of the actions we’re taking are directed at achieving that vision,” he said.
To start, Shuren described three key priorities related to improving core programs at the FDA:
- Implementing the FDA Improvement Act, which Congress passed in July.
- Issuing final guidance on the 2011 FDA plan for action on priority programs.
- Beginning to establish a national medical device surveillance system, which the FDA proposed last year.
More specifically, Shuren said the following key administration reforms would drive greater efficiency and predictability within the center:
- Smarter business practices: For instance, the process will be smoother when a lead reviewer changes.
- Organizational/internal structure: With additional dollars coming in, Shuren said, “we’re able to have a much more rational staff-to-frontline ratio.” That ratio is shifting from one to 27 to one to about a dozen, he said.
- Guidance document development: These will help clarify recommendations and expectations.
The FDA’s Entrepreneurs in Residence Program is currently working through implementation of recommendations from senior management, Shuren said, with plans to bring the changes public. If U.S. patients are going to have first access to medical devices, he said, it must be easier to start early feasibility studies here and the market must be more attractive. The industry will see a big impact, Shuren said, if pre-market burden can be reduced.
When it comes to priorities on post-market surveillance, Shuren reminded attendees that the national system is governed by a variety of stakeholders. One step, he said, is to establish a planning board. And the FDA is set to issue a final rule on establishing a unique device identification system in the U.S., Shuren said.
The outdated Manufacturer and User Facility Device Experience, the FDA’s adverse event database known as MAUDE, is scheduled to be replaced, Shuren said. A prototype will be released within a few months. The FDA has also released MedWatcher, a mobile app that lets users submit reports of serious medical device problems to the FDA.
Photo: Dr. Jeffrey Shuren