federal_register: E9-20415

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E9-20415 Microbiology Devices; Reclassification of Herpes Simplex Virus Types 1 and 2 Serological Assays Proposed Rule The Food and Drug Administration (FDA) is proposing to amend its device classification regulations by correcting the regulation classifying herpes simplex virus (HSV) serological assays by removing the reference to HSV serological assays other than type 1 and type 2. When reclassifying this device, FDA mistakenly distinguished between HSV serological assays type 1 and type 2 and all other HSV serological assays. At that time, and today, the only preamendments HSV serological assays FDA was aware of were type 1 and type 2, and therefore, the classification of HSV assays other than type 1 and type 2 was incorrect. FDA is correcting the classification of this device to eliminate possible confusion resulting from this error. Elsewhere in this issue of the Federal Register, we are publishing a companion direct final rule. This proposed rule will provide a procedural framework to finalize the rule in the event we receive significant adverse comment and withdraw the direct final rule. 2009-08-25 2009 8 https://www.federalregister.gov/documents/2009/08/25/E9-20415/microbiology-devices-reclassification-of-herpes-simplex-virus-types-1-and-2-serological-assays https://www.govinfo.gov/content/pkg/FR-2009-08-25/pdf/E9-20415.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is proposing to amend its device classification regulations by correcting the regulation classifying herpes simplex virus (HSV) serological assays by removing the reference to HSV serological assays other than...

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