Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA or Agency) has identified a list of class II devices that, when finalized, will be exempt from premarket notification requirements, subject to certain limitations. FDA is publishing this notice of that determination and requesting public comment in accordance with procedures established by the 21st Century Cures Act. This notice does not represent FDA's final determination with respect to the class II devices included in this document. FDA will review any comments submitted within the 60-day comment period and will consider whether the list of class II devices should be modified prior to publication of its final determination in the Federal Register.
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; request for comments. SUMMARY: The Food and Drug Administration (FDA or Agency) has identified a list of class II devices that, when finalized, will be exempt from premarket notification requirements, subject to certain limitations. FDA is publishing this notice of that determination and requesting public comment in accordance with procedures established by the 21st ( printed page 13610) Century Cures Act. This notice does not represent FDA's final determination with respect to the class II devices included in this document. FDA will review any comments submitted within the 60-day comment period and will consider whether the list of class II devices should be modified prior to publication of its final determination in the Federal Register . DATES: Submit either electronic or written comments on the notice by May 15, 2017. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before May 15, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of May 15, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. ADDRESSES: You may submit comments as follows: Electronic…
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
Citation: 82 FR 13609
