![]() ![]() for devices not exempt from premarket notification, obtain a substantial equivalence determination (Sections 510(k) and 513(i) of the FD&C Act, and 21 CFR 807.100) from FDA prior to marketing the device.įor additional information on specific device classification, please refer to the Code of Federal Regulations, of Title 21 in Parts 862 to 892 and FDA's product classification database.address the specific risks (Section 513(a)(1)(B) of the FD&C Act) to health identified, either by meeting the recommendations in the guidance/guidelines or by some other means that provides equivalent assurances of safety and effectiveness and.conform to the general controls in Section 513(a)(1)(A) of the Federal Food Drug & Cosmetic Act (the Act).Thus, a manufacturer who intends to market a device within a generic type of device covered by these documents must: While these documents describe a means by which a device may comply with the requirement of special controls, the risks to health identified in these documents must be addressed. These documents set forth the special controls for the applicable Class II devices. This page lists special controls guidance and guideline documents developed by CDRH and CBER.ĭevices classified into class II are devices for which special controls, combined with general controls, are necessary to provide reasonable assurance of safety and effectiveness.
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