CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES > SUBPART C—Clinical Laboratory Instruments (§862.2050 to §862.2920) > 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.

Code of Federal Regulations

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