§ 886.4445. Permanent magnet.
121 words·~1 min read·
/us/cfr/t21/s§ 886.4445·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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 management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 66 FR 38813, July 25, 2001; 90 FR 55992, Dec. 4, 2025]