21 C.F.R. § 892.1940 Radiologic quality assurance instrument.
Title 21 - Food and Drugs
(a) Identification. A radiologic quality assurance instrument is a device intended for medical purposes to measure a physical characteristic associated with another radiologic device. (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 §892.9. 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. [53 FR 1567, Jan. 20, 1988, as amended at 66 FR 38819, July 25, 2001]
Title 21: Food and Drugs
PART 892—RADIOLOGY DEVICES
Subpart B—Diagnostic Devices
§ 892.1940 Radiologic quality assurance instrument.
