FDA pledges tougher scrutiny on medical device market
The Food and Drug Administration pledges to do a better job policing the safety of medical devices once the products are on the market. The plan comes days after Democrats , who promise more aggressive oversight of the FDA, wrested majority from Republicans in the US House of Representatives and -- apparently -- the Senate.
The plan the FDA announced today ensures that it is better able to detect and take action on risks for thousands of medical devices. The agency is under fire for underestimating long-term heart risks attributed to drug-eluting stents, manufactured by such companies as Natick's Boston Scientific Corp. Next month it will convene an advisory panel to discuss the latest studies.
Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, called the plan a key step in the agency's attempt to obtain more funding to shore up its surveillance of the safety of devices.
"It’s very hard to get additional resources if you don’t have an actual program, an actual plan laid out," Schultz said today. "Believe me, I’ll be doing everything I can to encourage people to give us those resources."
Schultz said the timing of the report had nothing to do with national elections that shifted the balance of Congressional power from Republicans to Democrats.
The more sweeping change that the agency proposes is mandatory use of an electronic reporting system for serious side effects, as a replacement for time-consuming paper reports. Already, the FDA has assembled a network of 350 hospitals who report problems with devices, shortening the time it takes for the agency to learn about problems. Schultz said it more aggressively tap that database.
In addition, devices could carry "unique identifiers" that make it easier to track them down, permitting more focused recalls of problematic models.
Part of the changes outlined by the FDA were structural to make sure that various parts of the agency better work together as they handle review of device applications, safety monitoring after devices are on the market and enforcement actions.
