The U.S. Food and Drug Administration is overhauling the approval process for most medical devices. The 510(k) process allows medical devices to be marketed if they are similar to products already greenlit by regulators. A recent investigation highlighted the process’s risks. The FDA now wants companies to base new products on devices no older than 10 years. The new pathway for medical devices is expected to be finalized next year.
As a young health reporter, I spent a lot of time understanding how medical devices make it to the U.S. market. Frankly, it's shocking. The risks of the system were no secret. Report after report suggested getting rid of the 510(k) process or overhauling the whole system. Finally, after a decade or more of people and institutions raising concerns, the FDA is moving in that direction.
“What we want to do is constantly push the market toward incorporating better technology and better capabilities by advancing the predicates and always looking forward so the ... predicates the device companies are using as the basis of their approvals are constantly incorporating newer and better technology to make the devices better and safer,” said FDA Commissioner Scott Gottlieb.
FDA to overhaul more than 40-year-old process for approving medical devices (510K) that some say puts consumers at risk. https://lnkd.in/eT6ymYF
Recent announcement by U.S. Department of Health and Human Services (HHS) FDA describes a list of upcoming changes to Medical Device Safety Action Plan. #healthcarecompliance #sunhawkconsulting