Draft Guidance for Industry and Food and Drug Administration Staff Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices
The goal of this document is:
- To outline FDA’s enforcement policy with regard to premarket notification requirements for certain in vitro diagnostic and radiology devices listed below in section D, 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 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.
- For the Class I devices that are the subject of this guidance document, FDA intends 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 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.
FDA intends to exempt certain 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.
For more information on this guidance you and to understand the list of devices subject to enforcement discretion can go to the following link:http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM262153.pdf or contact mdi at email@example.com REF:Devices subject to enforcement discretion.