21 CFR § 880.6430 General Hospital and Personal Use Devices

§ 880.6430 Liquid medication dispenser.

Current through Sep 8, 2026 · Read all of Part 880

(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 management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38806, July 25, 2001; 90 FR 55988, Dec. 4, 2025]

← § 880.6375 Patient lubricant.§ 880.6450 Skin pressure protectors. →