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The Food and Drug Administration issued a new guidance today that exempts still more medical devices — some of them consumer devices — from its regulatory scope. This means the makers of these devices, some of which are connected to apps, no longer have to go through the FDA’s 510(k) review process before they bring their product to market.
The affected devices are largely clinical, including things like anesthesiology, cardiovascular, and dental devices. But a number of consumer mobile and digital health products are exempted as well, including thermometers, stethoscopes, talking first aid kits, hearing aids, fertility diagnostic devices, and exercise equipment.
“The FDA believes devices . . . are sufficiently well understood and do not present risks that require premarket 21 notification (510(k)) review to assure their safety and effectiveness,” the FDA said in the advisory today.
“This is big news, and a huge boost to the mHealth industry,” Epstein Becker Green compliance attorney Brad Thompson said in a note to VentureBeat Friday morning.
“It shows that FDA is being extremely practical in reviewing its own practices and updating its regulatory requirements where the risks simply do not merit the investment of regulatory resources,” Thompson said. “My hat is off to FDA.”
The FDA will now open a 60-day comment period before issuing a final ruling on the matter.
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