Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA, Agency, or we) is proposing on its own initiative to reclassify optical diagnostic devices for melanoma detection and electrical impedance spectrometers, both of which are postamendments class III devices (product codes OYD and ONV, respectively), into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation with the name "computer-aided devices which provide adjunctive diagnostic information about lesions suspicious for melanoma," along with special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness for these devices. If finalized, this order will reclassify these devices from class III to class II and the submission of a premarket approval application (PMA) for these devices will no longer be required, and instead the submission of a premarket notification (510(k)) will be required.
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] AGENCY: Food and Drug Administration, Health and Human Services (HHS). ACTION: Proposed amendment; proposed order; request for comments. SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is proposing on its own initiative to reclassify optical diagnostic devices for melanoma detection and electrical impedance spectrometers, both of which are postamendments class III devices (product codes OYD and ONV, respectively), into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation with the name “computer-aided devices which provide adjunctive diagnostic information about lesions suspicious for melanoma,” along with special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness for these devices. If finalized, this order will reclassify these devices from class III to class II and the submission of a premarket approval application (PMA) for these devices will no longer be required, and instead the submission of a premarket notification (510(k)) will be required. DATES: Submit either electronic or written comments on the proposed order by August 29, 2022. Please see section X of this document for the proposed effective date when the new requirements apply and for the proposed effective date of a final order based on this pro…
Other Federal Register documents from the same docket.
Citation: 87 FR 39025
