21 CFR Part 878 - GENERAL AND PLASTIC SURGERY DEVICES
Title 21 published on 2012-04-01
The following are only the Rules published in the Federal Register after the published date of Title 21.
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This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.
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Title 21 published on 2012-04-01
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 878 after this date.
GPO FDSys XML | Text type regulations.gov FR Doc. 2013-10982 RIN Docket No. FDA-2013-N-0461 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed Order. Submit either electronic or written comments on this proposed order by August 7, 2013. See section XI for the proposed effective date of a final order based on this proposed order. 21 CFR Part 878 The Food and Drug Administration (FDA) is proposing to reclassify ultraviolet (UV) lamps intended to tan the skin from class I (general controls) exempt from premarket notification to class II (special controls) and subject to premarket notification, and to rename them sunlamp products. FDA is also designating special controls that are necessary to provide a reasonable assurance of the safety and effectiveness of the device. FDA is proposing this reclassification on its own initiative based on new information.
GPO FDSys XML | Text type regulations.gov FR Doc. 2013-06826 RIN Docket No. FDA-2013-N-0011 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendment. This rule is effective March 26, 2013. 21 CFR Parts 814, 822, 862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 882, 884, 886, 888, 890, and 892 The Food and Drug Administration (FDA) is amending certain medical device regulations to correct minor errors in the Code of Federal Regulations (CFR). This action is editorial in nature and is intended to provide accuracy and clarity to the Agency's regulations.