Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA or Agency) is announcing a list of class II devices that the Agency has determined based on established factors to no longer require premarket notification to provide reasonable assurance of safety and effectiveness, subject to certain limitations. FDA is publishing this notice of that determination in accordance with procedures established by the 21st Century Cures Act. This notice represents FDA's final determination with respect to the list of class II devices proposed in a March 14, 2017, Federal Register document. The exemptions in this notice will decrease regulatory burdens on the medical device industry and will eliminate 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 [Docket No. FDA-2017-N-1129] AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing a list of class II devices that the Agency has determined based on established factors to no longer require premarket notification to provide reasonable assurance of safety and effectiveness, subject to certain limitations. FDA is publishing this notice of that determination in accordance with procedures established by the 21st Century Cures Act. This notice represents FDA's final determination with respect to the list of class II devices proposed in a March 14, 2017, Federal Register document. The exemptions in this notice will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. FOR FURTHER INFORMATION CONTACT: Bryce Bennett, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5244, Silver Spring, MD 20993, email: Gregory.Bennett@fda.hhs.gov . SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of March 14, 2017 ( 82 FR 13609 ), FDA issued a notice proposing to exempt a list of class II devices from the premarket notification requirements under section 510(k) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) ( 21 U.S.C. 360(k) ), subject to certain limitat…
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
Medical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments
Medical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments
Citation: 82 FR 31976
