The FDA is making a strong commitment to help the landscape for the creation of medical devices.
In a Oct. 29, blog post, William Maisel, M.D., M.P.H., the FDA’s Deputy Center Director for Science and Chief Scientist for its Center for Devices and Radiological Health, said the agency recently reviewed a number of products for people with disabilities, and approved, cleared or allowed manufacturers to market them.
"We foster an approach that enables our staff to interact with device manufacturers and clarify our agency’s expectations for product evaluation," he wrote. "This communication can help new devices get to market in a timely fashion. We also listen to patients’ feedback, which helps us determine which devices may be particularly useful."
He explained the agency is encouraging more medical device development for the disabled, and when making regulatory decisions, they will consider all aspects.
"Each of the products recently approved or cleared by the agency has benefits that outweigh its risks. For example, in June we allowed marketing of ReWalk, a first-of-its-kind, motorized device. Risks associated with the exoskeleton-like device include pressure sores and injuries from falls. But the big benefit is that it can help patients with complete or partial paraplegia to actually walk in their homes and communities."