The U.S. Food and Drug Administration (FDA) has released a guidance that will relax the agency's requirements for 510(k) clearance for some medical devices.
The FDA has identified certain class I and class II in vitro diagnostic (IVD) and radiology devices that have established safety and effectiveness profiles and for which it intends to exempt from the 510(k) process. Radiology devices on the list include certain collimators, film cassettes, film processors, and digitizers.
In the interim period while the FDA proposes and finalizes such down classification and exemption changes, the agency said it intends to exercise enforcement discretion with regard to 510(k) submission requirements for these devices. This action is being taken as an interim measure in anticipation of a rule reclassifying the identified class II devices as class I and exempting all of these devices from premarket review, according to the FDA.
The full guidance can be found on the FDA website.
