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The latest agreement to fund medical device fees in the United States enjoys broad industry support, but patient groups are calling for expanded use of real-world evidence to monitor devices after they reach the market. The agreement includes higher fees for foreign companies, greater transparency regarding staffing at the medical device division, and the conversion of the TAP program into a permanent program.
The U.S. Food and Drug Administration (FDA) explains the regulatory and design standards that manufacturers of over-the-counter medical devices should consider, from usability and labeling to clinical evidence and connected software. It also explains when a new 510(k), De Novo request, or PMA application may be required when converting a device from prescription use to direct-to-consumer use.