Jul 12, 2011

New draft guidance from the US Food and Drug Administration would reclassify some in vitro and radiology devices from Class II to Class I and exempt them from premarket notification requirements.

The guidance lists certain clinical chemistry, hematology, immunology, microbiology and radiology devices that would qualify for the agency’s proposed 510(k) exemption. Finalization of the proposed rule would presumably lead to easier paths to entry into the US medical device market for qualifying manufacturers.

According to the regulator, the move to down-classify these products is appropriate because their safety and effectiveness have become well-established, obviating the need for 510(k) reviews. The FDA also plans to exempt some Class I in vitro and radiology devices from 510(k) review requirements.

Until finalization of the proposal, the agency will employ “enforcement discretion” in terms of 510(k) submission requirements for devices affected by the guidance. All other requirements these devices must meet—registration and listing, labeling, good manufacturing practices, and medical device reporting, for example—will remain in force.

The FDA is accepting public comment on the draft guidance have 90 days to submit comments electronically or in writing. 


  • Stewart Eisenhart