The FDA this week finalized a list of 1,003 Class II medical devices that will no longer require 510(k) clearances.
The list was drafted and published in March as part of the 21st Century Cures Act, looking to decrease the regulatory burden on the FDA and decrease costs for medical device companies.
Included on the list are dentures, cartridge syringes, surgical light sources, esophageal dilators, surgical drapes, forceps and umbilical clamps, perineal heaters, ophthalmoscopes and a wealth of other devices.
The federal watchdog noted that while the devices are exempt from 510(k) clearance, they are still under their regulatory control.
“An exemption from the requirement of premarket notification does not mean that the device is exempt from any other statutory or regulatory requirements, unless such exemption is explicitly provided by order or regulation. FDA’s determination that premarket notification is unnecessary to provide a reasonable assurance of safety and effectiveness for devices listed in this document is based, in part, on the assurance of safety and effectiveness that other regulatory controls, such as current good manufacturing practice requirements, provide,” the FDA wrote in its release.
The FDA added that any companies with pending 510(k) submissions for devices that are now exempt should contact their reviewers to discuss whether or not the review of their application should continue.
