FDA Issues Draft Guidance for New In Vitro and Radiology 510(k) Exemptions

Jul 19, 2011   

On July 12, 2011, the FDA issued a draft guidance which outlines FDAs enforcement policy regarding certain Class II medical devices and 510(k) premarket notification requirements. The draft guidance was issued in anticipation of a rule reclassifying certain in vitro and radiology Class II devices as Class I. A complete list of the devices can be found in the draft guidance. The reclassification of devices is one component of the agencys plan to overhaul the system for reviewing and clearing medical devices. Please see our previous report on the FDAs plan here and the FDAs draft guidance on in vitro companion diagnostic devices here.

The FDA classifies medical devices based on perceived risk using a 3-tier system. Class I medical devices have the lowest perceived risk, and do not require a formal FDA review before marketing. Class II medical devices have a higher perceived risk than Class I, and require the submission of a 510(k) premarket notification or premarket notification application (PMA). Class III medical devices have the highest perceived risk, and require the submission of a PMA. The draft guidance states that the enforcement of 510(k) requirements is to evaluate the safety and effectiveness of a device. According to the draft guidance, the FDA believes that the in vitro and radiology Class II devices now receiving a 510(k) exemption are sufficiently well-established and have sufficiently controlled the risks that are necessary to assure the safety and effectiveness; thus, those devices can now be reclassified as Class I.

The FDA is currently seeking public comment on the draft guidance; the deadline for submission is August 16, 2011.

The FDAs review of medical devices through the 510(k) process is complex. Fuerst Ittleman has extensive experience successfully navigating medical devices through FDA review. For more information on FDAs review of medical devices, please contact us at contact@fidjlaw.com.