Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA or the Agency) is publishing an order to exempt a list of class II devices from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for the listed class II devices. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. FDA is also amending the codified language for the listed class II devices to reflect this final determination. FDA is publishing this order in accordance with the section of the Federal Food, Drug, and Cosmetic Act (FD&C Act) permitting the exemption of a device from the requirement to submit a 510(k).
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, 866, 876, 880, and 884 [Docket No. FDA-2017-N-1129] AGENCY: Food and Drug Administration, HHS. ACTION: Final order. SUMMARY: The Food and Drug Administration (FDA or the Agency) is publishing an order to exempt a list of class II devices from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for the listed class II devices. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. FDA is also amending the codified language for the listed class II devices to reflect this final determination. FDA is publishing this order in accordance with the section of the Federal Food, Drug, and Cosmetic Act (FD&C Act) permitting the exemption of a device from the requirement to submit a 510(k). DATES: This order is effective June 5, 2018. FOR FURTHER INFORMATION CONTACT: Scott McFarland, Center for Devices and ( printed page 25911) Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 66, Rm. 4676, Silver Spring, MD 20993-0002, 301-796-6217. SUPPLEMENTARY INFORMATION: I. Statutory Background Section 510(k) of the FD&C Act ( 21 U.S.C. 360(k) ) and the implementing regulations, 21 CFR part 807, subpart E , require persons who intend…
Other Federal Register documents from the same docket.
Medical Devices; Exemptions From Premarket Notification for Class I and Class II Devices
Medical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments
Medical Devices; Exemptions From Premarket Notification: Class II Devices
Medical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments
Citation: 83 FR 25910
