Source: http://www.law.cornell.edu/cfr/text/21/876?quicktabs_7=1
Timestamp: 2013-12-09 02:02:47
Document Index: 258414204

Matched Legal Cases: ['art 876', 'art 876', 'art 876', '§ 876', '§ 876', '§ 876', '§ 876', '§ 876', '§ 876', '§ 351', '§ 360', '§ 360', '§ 360', '§ 360', '§ 371', 'art 876', 'arts 876']

21 CFR Part 876 - GASTROENTEROLOGY-UROLOGY DEVICES | Title 21 - Food and Drugs | Code of Federal Regulations | LII / Legal Information Institute
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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)
21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
48 FR 53023, Nov. 23, 1983, unless otherwise noted.
Title 21 published on 2013-04-01no entries appear in the Federal Register after this date. 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].It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.United States CodeUSC : Title 21 - FOOD AND DRUGS§ 351 - Adulterated drugs and devices§ 360 - Registration of producers of drugs or devices§ 360c - Classification of devices intended for human use§ 360e - Premarket approval§ 360j - General provisions respecting control of devices intended for human use21 USC § - § 371 - Regulations and hearings
Title 21 published on 2013-04-01The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 876 after this date.2013-06-28; vol. 78 # 125 - Friday, June 28, 201378 FR 38867 - Gastroenterology-Urology Devices; Reclassification of Implanted Blood Access Devices
typeregulations.gov FR Doc.2013-15504 RIN Docket No.FDA-2012-N-0303 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed order. Submit either electronic or written comments on the proposed order by July 29, 2013. See section XII for the proposed effective date of any final order that may publish based on this proposed order. 21 CFR Part 876 SummaryThe Food and Drug Administration (FDA) is issuing a proposed administrative order to reclassify the implanted blood access device preamendments class III device into class II (special controls) and subject to premarket notification, and to further clarify the identification. FDA is proposing this reclassification under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) based on new information pertaining to the device. This action implements certain statutory requirements.
2013-04-04; vol. 78 # 65 - Thursday, April 4, 201378 FR 20268 - Effective Date of Requirement for Premarket Approval for Three Class III Preamendments Devices; Reclassification of Sorbent Hemoperfusion Devices for the Treatment of Poisoning and Drug Overdose
typeregulations.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 SummaryThe 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.