21 C.F.R. § 880.6430

Current through October 31, 2024
Section 880.6430 - Liquid medication dispenser
(a)Identification. A Liquid medication dispenser is a device intended for medical purposes that is used to issue a measured amount of liquid medication.
(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 § 880.9 . 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.

21 C.F.R. §880.6430

45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38806 , July 25, 2001