§ 862.2050. General purpose laboratory equipment labeled or promoted for a specific medical use.
139 words·~1 min read·
/us/cfr/t21/s§ 862.2050·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.
(b)Classification. Class I (general controls). The device is identified in paragraph
(a)of this section and is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. 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 16122, May 1, 1987, as amended at 66 FR 38788, July 25, 2001; 90 FR 55980, Dec. 4, 2025]
Connections2 cite this
Cited by 2 sections
Citation graph
cites case law
§ 862.2050
General purpose laboratory equipment labeled or promoted for a specific medical use.
Fed. Reg.×2
Cites 0Cited by 2 across 1 source