Guidance for Industry: Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices
This document is intended
- To describe FDA’s intent with regard to enforcement of premarket notification (510(k)) requirements for certain in vitro diagnostic and radiology devices under 21 CFR Part 807, Subpart E.
- To propose the down classification and exemption from 510(k) requirements of the class II devices that are the subject of this guidance document because it believes the safety and effectiveness of these devices is sufficiently well established and they have sufficiently controlled risks that general controls are sufficient and a 510(k) review is not necessary to assure the safety and effectiveness of such devices, subject to the limitations to the exemption criteria found in 21 CFR 862.9, 21 CFR 864.9, 21 CFR 866.9, and 21 CFR 892.9.
- To propose an amendment to the classification regulations to exempt these devices from 510(k) requirements that currently apply under the reserved criteria of section 510(l) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), subject to the limitations on exemption criteria found in 21 CFR 862.9. See 65 FR 2296.
- In the interim period while FDA proposes and finalizes such down classification and exemption, FDA intends to Contains Nonbinding Recommendations exercise enforcement discretion with regard to 510(k) submission requirements for the devices listed in this guidance.
- 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 believes 510(k) review is not necessary to assure safety and effectiveness. While FDA intends to exempt these devices from the 510(k) requirement through rulemaking that would reclassify the Class II devices and amend the classification regulations of the Class I devices, FDA no longer believes it is necessary to review premarket notification (510(k)) submissions for these devices before they enter the market and intends to exercise enforcement discretion for these devices concerning the 510(k) requirement.
PLEASE BE AWARE THAT THIS IS YOUR CHANCE TO MAKE YOUR THOUGHTS TO BE KNOWN: Written comments and suggestions may be submitted at any time for FDA consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. When submitting comments, refer to Docket No FDA-2011-D-0476
Or you can send your comments anytime at firstname.lastname@example.org and REF: Guidance on Enforcement Policy Premarket notification IVD.
For the list of In Vitro Diagnostic and Radiology Devices for Which FDA Intends to Exercise Enforcement Discretion with Regard to Premarket Notification Requirements on this guidance you can go to the following link: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM283948.pdf