Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA) is issuing a final order reclassifying optical diagnostic devices for melanoma detection (product code OYD) and electrical impedance spectrometers (product code ONV), both postamendments class III device types, into class II (special controls), subject to premarket notification. FDA is also renaming and codifying these devices under the new classification regulation named "software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer." FDA is also establishing the special controls necessary to provide a reasonable assurance of safety and effectiveness of these devices.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration 21 CFR Part 878 [Docket No. FDA-2022-N-0794] ( printed page 14445) AGENCY: Food and Drug Administration, HHS. ACTION: Final amendment; final order. SUMMARY: The Food and Drug Administration (FDA) is issuing a final order reclassifying optical diagnostic devices for melanoma detection (product code OYD) and electrical impedance spectrometers (product code ONV), both postamendments class III device types, into class II (special controls), subject to premarket notification. FDA is also renaming and codifying these devices under the new classification regulation named “software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer.” FDA is also establishing the special controls necessary to provide a reasonable assurance of safety and effectiveness of these devices. DATES: This order is effective April 24, 2026. FOR FURTHER INFORMATION CONTACT: Jessica Carr, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4522, Silver Spring, MD 20993, 301-796-5997, Jessica.Carr@fda.hhs.gov . SUPPLEMENTARY INFORMATION: I. Background—Regulatory Authorities The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended, establishes a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act ( 21 U.S.C. 360c ) esta…
Other Federal Register documents from the same docket.
Citation: 91 FR 14445
