Posted by Michael Wonder on 13 Sep 2023
FDA proposes changes to key approval pathway for medical devices, five years after promising
12 September 2023 - Five years after promising to fix a flawed regulatory pathway widely used by medical device manufacturers, the FDA has issued new guidelines to improve its so-called 510(k) program that has long been lambasted for letting risky devices fall through the cracks.
Most medical device companies do not have to test their products on people in order to secure clearance from the FDA — they simply have to show they’re “substantially equivalent” to devices already on the market, called “predicates.
