21 CFR 886.5900 - Electronic vision aid.

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There are 3 Updates appearing in the Federal Register for 21 CFR Part 886. View below or at eCFR (GPOAccess)
§ 886.5900 Electronic vision aid.

(a)Identification. An electronic vision aid is an AC-powered or battery-powered device that consists of an electronic sensor/transducer intended for use by a patient who has impaired vision or blindness to translate visual images of objects into tactile or auditory signals.

(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 § 886.9.

[ 55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63014, Dec. 7, 1994; 66 FR 38814, July 25, 2001]

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United States Code

Title 21 published on 2015-12-03

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 886 after this date.

  • 2016-09-22; vol. 81 # 184 - Thursday, September 22, 2016
    1. 81 FR 65279 - Medical Devices; Ophthalmic Devices; Classification of Strabismus Detection Device
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective September 22, 2016. The classification was applicable on June 8, 2016.
      21 CFR Part 886

Title 21 published on 2015-12-03.

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.

  • 2016-09-22; vol. 81 # 184 - Thursday, September 22, 2016
    1. 81 FR 65279 - Medical Devices; Ophthalmic Devices; Classification of Strabismus Detection Device
      GPO FDSys: XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective September 22, 2016. The classification was applicable on June 8, 2016.
      21 CFR Part 886