21 CFR 886.4445 - Permanent magnet.

§ 886.4445 Permanent magnet.

(a)Identification. A permanent magnet is a nonelectric device that generates a magnetic field intended to find and remove metallic foreign bodies from eye tissue.

(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. 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, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

[ 52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 66 FR 38813, July 25, 2001]

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].

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United States Code

Title 21 published on 09-Nov-2018 03:23

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

  • 2018-10-19; vol. 83 # 203 - Friday, October 19, 2018
    1. 83 FR 52973 - Medical Devices; Ophthalmic Devices; Classification of the Intranasal Electrostimulation Device for Dry Eye Symptoms
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective October 19, 2018. The classification was applicable on May 17, 2018.
      21 CFR Part 886