Title 21

SECTION 862.2050

862.2050 General purpose laboratory equipment labeled or promoted for a specific medical use.

§ 862.2050 General purpose laboratory equipment labeled or promoted for a specific medical use.

(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 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 16122, May 1, 1987, as amended at 66 FR 38788, July 25, 2001]

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