FDA Updating Medical Device Review Process

At the heart of new actions FDA is taking is a new goal: ensuring the FDA is consistently first among the world's regulatory agencies to identify and act upon safety signals related to medical devices.

The U.S. Food and Drug Administration is about to announce several actions aimed at fundamentally modernizing the process for medical device review, particularly as it relates to the 510(k) process, FDA Commissioner Dr. Scott Gottlieb, M.D., and Dr. Jeff Shuren, M.D., director of the Center for Devices and Radiological Health, said in a Nov. 20 statement on the agency's updates to its Medical Device Safety Action Plan.

They said the actions will be unveiled next week. At the heart of those actions is the statement's announcement of a new goal: ensuring the FDA is consistently first among the world's regulatory agencies to identify and act upon safety signals related to medical devices.

The agency regulates more than 190,000 different devices that are manufactured by more than 18,000 firms in more than 21,000 medical device facilities worldwide. "These products provide immense and often life-saving benefits to millions of patients. On average, we approve, clear or grant marketing authorization to approximately 12 new or modified devices every business day after carefully determining -- based on valid scientific evidence -- that the devices are safe and effective. These decisions take into consideration whether the benefits of the devices outweigh their risks to patients," they wrote. "Unfortunately, the FDA cannot always know the full extent of the benefits and risks of a device before it reaches the market. Even reasonably-sized premarket trials cannot be expected to reveal everything that could eventually become known about a novel medical device once it's more widely distributed and used under real-world conditions, in broader patient populations, and by a broader range of clinicians."

The statement then explains that the agency is "evolving beyond our current post-market surveillance system -- which is largely passive and relies on device users to report problems to us, sometimes resulting in underreporting. We're moving," it says, "to an active surveillance system that relies on real-world evidence and timely receipt of robust safety information. We have long recognized the systemic weaknesses of the passive system – a challenge faced by other countries – and we prioritized this area for regulatory reform efforts."

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