The FDA is significantly revamping the way it clears most medical devices for U.S. marketing, planning to rely far less on comparisons with much older products already on the market, according to a report in The Wall Street Journal.
This reliance by the federal agency has been regarded as one of the weaknesses in the way it allows medical devices to be sold in the U.S., leading to problem devices like defective metal hip implants and bloodstream filters that fractured. Instead of insisting on full studies of such products, the FDA has allowed the standard to be “substantial equivalence” to already-cleared ones.
Some of the comparison products—known as “predicate devices”—were approved soon after the agency began regulating medical devices in 1976. More than 80% of medical devices in the U.S. have since gained market entry under this standard.
“It’s time to fundamentally modernize an approach first adopted in 1976, when Congress considered the vast diversity of devices” entering the U.S. market, senior FDA officials said in a statement disclosed Monday. The officials are FDA Commissioner Scott Gottlieb and Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health.