TITLE 21 - FOOD AND DRUGS

CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 862 - CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

subpart c - CLINICAL LABORATORY INSTRUMENTS

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 regulations 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]