21 CFR 872.3970 - Interarticular disc prosthesis (interpositional implant).

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§ 872.3970 Interarticular disc prosthesis (interpositional implant).
(a) Identification. An interarticular disc prosthesis (interpositional implant) is a device that is intended to be an interface between the natural articulating surface of the mandibular condyle and glenoid fossa.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before March 30, 1999, for any interarticular disc prosthesis (interpositional implant) that was in commercial distribution before May 28, 1976, or that has on or before March 30, 1999, been found to be substantially equivalent to an interarticular disc prosthesis (interpositional implant) that was in commercial distribution before May 28, 1976. Any other interarticular disc prosthesis (interpositional implant) shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
[59 FR 65478, Dec. 20, 1994, as amended at 63 FR 71746, Dec. 30, 1998]

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.

  • 2014-08-25; vol. 79 # 164 - Monday, August 25, 2014
    1. 79 FR 50551 - Medical Devices; Technical Amendment
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective August 25, 2014.
      21 CFR Parts 862, 864, 866, and 872

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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 872 after this date.

  • 2014-09-18; vol. 79 # 181 - Thursday, September 18, 2014
    1. 79 FR 56027 - Dental Devices; Reclassification of Salivary Stimulatory System, To Be Renamed Electrical Salivary Stimulator System
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      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Proposed Order.
      Submit either electronic or written comments by December 17, 2014. Please see section IX of this document for the proposed effective date of any final order that may publish based on this proposed order.
      21 CFR Part 872