Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA or we) is classifying the herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
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 866 [Docket No. FDA-2018-N-3596] AGENCY: Food and Drug Administration, HHS. ACTION: Final order. SUMMARY: The Food and Drug Administration (FDA or we) is classifying the herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens. DATES: This order is effective October 17, 2018. The classification was applicable on May 13, 2014. FOR FURTHER INFORMATION CONTACT: Scott McFarland, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4676, Silver Spring, MD, 20993-0002, 301-796-6217, scott.mcfarland@fda.hhs.gov . SUPPLEMENTARY INFORMATION: I. Background Upon request, FDA has classified the herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel as class II (special controls), which we have determined will provide a reasonable assurance of safe…
Citation: 83 FR 52313
