FDA Exempts Certain In Vitro and Radiology Devices from 510(k) Requirements
On December 20, 2011, the U.S. Food and Drug Administration (FDA) published guidance entitled “Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices.” The guidance exempts certain Class I and Class II in vitro and radiology devices from premarket notification (510(k)) requirements. A complete list of the specified devices can be found in the guidance document. The FDA received five public comments on the draft guidance that was published on July 12, 2011. Please see our previous report for more information regarding the draft guidance document.
The FDA classifies medical devices based on perceived risk using a 3-tier system. Class I medical devices have the lowest perceived risk, and generally 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) or premarket notification application (PMA) to establish the safety and effectiveness of the device. Class III medical devices have the highest perceived risk, and require the submission of a PMA. The Agency believes the safety and effectiveness of the newly exempt devices is sufficiently well established and a 510(k) review is not necessary.
The guidance states that the FDA intends to propose an amendment to the classification regulations to exempt the specified Class I devices from the 510(k) requirements that apply pursuant to section 510(I) of the Federal Food, Drug, and Cosmetic Act. In addition, the FDA intends to propose the downclassification and exemption from the 510(k) requirements for the specified Class II devices. The FDA states 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. In the interim period while the FDA finalizes such exemption and downclassification, the FDA intends to exercise enforcement discretion with regard to 510(k) submission requirements for the devices listed in the guidance.
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 firstname.lastname@example.org.