21 CFR 876.5970 - Hernia support.

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There are 4 Updates appearing in the Federal Register for 21 CFR 876. View below or at eCFR (GPOAccess)
§ 876.5970 Hernia support.
(a) Identification. A hernia support is a device, usually made of elastic, canvas, leather, or metal, that is intended to be placed over a hernial opening (a weakness in the abdominal wall) to prevent protrusion of the abdominal contents. This generic type of device includes the umbilical truss.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records, and § 820.198, regarding complaint files.
[48 FR 53023, Nov. 23, 1983, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38802, July 25, 2001]

Title 21 published on 2014-04-01

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.

  • 2014-07-25; vol. 79 # 143 - Friday, July 25, 2014
    1. 79 FR 43241 - Gastroenterology-Urology Devices; Reclassification of Implanted Blood Access Devices
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective July 25, 2014.
      21 CFR Part 876

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United States Code

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 876 after this date.

  • 2014-07-25; vol. 79 # 143 - Friday, July 25, 2014
    1. 79 FR 43241 - Gastroenterology-Urology Devices; Reclassification of Implanted Blood Access Devices
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective July 25, 2014.
      21 CFR Part 876