21 CFR Part 876 - GASTROENTEROLOGY-UROLOGY DEVICES
- SUBPART A — General Provisions (§§ 876.1 - 876.9)
- SUBPART B — Diagnostic Devices (§§ 876.1075 - 876.1800)
- SUBPART C — Monitoring Devices (§§ 876.2040 - 876.2040)
- SUBPART D — Prosthetic Devices (§§ 876.3350 - 876.3750)
- SUBPART E — Surgical Devices (§§ 876.4020 - 876.4890)
- SUBPART F — Therapeutic Devices (§§ 876.5010 - 876.5990)
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.
For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.
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.
This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].
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21 USC § -
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 876 after this date.
GPO FDSys XML | Text type regulations.gov FR Doc. 2013-07730 RIN Docket No. FDA-2013-N-0195 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed order. Submit written or electronic comments on this proposed order by May 6, 2013. FDA intends that, if a final order based on this proposed order is issued, anyone who wishes to continue to market the sorbent hemoperfusion devices for the treatment of hepatic coma and metabolic disturbances; cranial electrotherapy stimulator for the treatment of depression, anxiety, and insomnia; or transilluminator for breast evaluation will need to file a PMA or a notice of completion of a PDP within 90 days of the effective date of the final order. See section XIII of this document for the proposed effective date of any final order that may publish based on this proposed order. 21 CFR Parts 876, 882, and 892 The Food and Drug Administration (FDA) is issuing a proposed administrative order to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following three class III preamendments devices: Sorbent hemoperfusion devices for the treatment of hepatic coma and metabolic disturbances; cranial electrotherapy stimulator for the treatment of depression, anxiety, and insomnia; and transilluminator for breast evaluation. FDA is also announcing the opportunity for interested persons to request that the Agency change the classification of any of the aforementioned devices based on new information. In addition, FDA is proposing to reclassify sorbent hemoperfusion devices for the treatment of poisoning and drug overdose, a preamendments class III device, into class II (special controls) based on new information respecting the device. This action implements certain statutory requirements.
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.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-15024 RIN Docket No. FDA-2012-N-0303 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule. Submit either electronic or written comments on the proposed rule by September 18, 2012. Please see section XIII of this document for the effective date of any final rule that may publish based on this proposal. 21 CFR Part 876 The Food and Drug Administration (FDA) is proposing to reclassify the implanted blood access device preamendments class III device into class II (special controls). FDA is proposing this reclassification on its own initiative based on new information. FDA is taking this action under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA), and the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).