In an effort to simplify the approval process for low-risk medical products, FDA has exempted 107 medical devices from its 510k premarket notification regulations. This list was released as part of the August 1st draft guidance, allowing devices that are “sufficiently well understood and do not present risks that require premarket notification review to assure their safety and efficacy” to be marketed without a 510k submission, given that the device meets all other regulatory requirements.
FDA has granted exemptions for medical devices such as portable air compressors, fluid-filled teething rings, surgical lights, and obstetrical forceps.
To read Joseph Keenan’s article on Fierce Medical Devices, click here.