21 CFR 882.1790 - Ocular plethysmograph.

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There are 2 Updates appearing in the Federal Register for 21 CFR 882. View below or at eCFR (GPOAccess)
§ 882.1790 Ocular plethysmograph.
(a) Identification. An ocular plethysmograph is a device used to measure or detect volume changes in the eye produced by pulsations of the artery, to diagnose carotid artery occlusive disease (restrictions on blood flow in the carotid artery).
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before September 21, 2004, for any ocular plethysmograph that was in commercial distribution before May 28, 1976. Any other ocular plethysmograph shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
[44 FR 51730, Sept. 4, 1979, as amended at 52 FR 17739, May 11, 1987; 69 FR 34920, June 23, 2004]

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.

  • 2014-07-08; vol. 79 # 130 - Tuesday, July 8, 2014
    1. 79 FR 38457 - Medical Devices; Neurological Devices; Classification of the Transcranial Magnetic Stimulator for Headache
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective August 7, 2014. The classification was applicable on December 13, 2013.
      21 CFR Part 882

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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 882 after this date.

  • 2014-07-08; vol. 79 # 130 - Tuesday, July 8, 2014
    1. 79 FR 38457 - Medical Devices; Neurological Devices; Classification of the Transcranial Magnetic Stimulator for Headache
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective August 7, 2014. The classification was applicable on December 13, 2013.
      21 CFR Part 882