Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA, Agency, or we) identified a list of class I devices and class II devices that are now exempt from premarket notification requirements, subject to certain limitations. FDA published the lists of final determinations in accordance with procedures established by the 21st Century Cures Act (Cures Act). Although each classification regulation for each such type of device shall be deemed amended to incorporate such exemption, we are publishing this final order to amend the codified language for each listed class I and class II device's classification regulation to reflect the final determinations. FDA's action decreases regulatory burden on the medical device industry and eliminates private costs and expenditures required to comply with certain Federal regulations.
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 Parts 862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 882, 884, 886, 888, 890, and 892 [Docket Nos. FDA-2017-N-1129 and FDA-2017-N-1610] AGENCY: Food and Drug Administration, HHS. ACTION: Final amendment; final order. SUMMARY: The Food and Drug Administration (FDA, Agency, or we) identified a list of class I devices and class II devices that are now exempt from premarket notification requirements, subject to certain limitations. FDA published the lists of final determinations in accordance with procedures established by the 21st Century Cures Act (Cures Act). Although each classification regulation for each such type of device shall be deemed amended to incorporate such exemption, we are publishing this final order to amend the codified language for each listed class I and class II device's classification regulation to reflect the final determinations. FDA's action decreases regulatory burden on the medical device industry and eliminates private costs and expenditures required to comply with certain Federal regulations. DATES: This order is effective December 30, 2019. FOR FURTHER INFORMATION CONTACT: Karen Fikes, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5502, Silver Spring, MD 20993, 301-796-9603, email: karen.fikes@fda.hhs.gov . SUPPLEMENTARY INFORMATION: I. Background The Cures Act ( Pub. L. 114-255 ) was signed into …
Citation: 84 FR 71794
