21 C.F.R. § 872.5550

Current through October 31, 2024
Section 872.5550 - Teething ring
(a)Identification. A teething ring is a divice intended for use by infants for medical purposes to soothe gums during the teething process.
(b)
(1)Classification. Class I if the teething ring does not contain a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.
(2) Class II (special controls) if the teething ring contains a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9 .

21 C.F.R. §872.5550

52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63009, Dec. 7, 1994; 84 FR 71812 , Dec. 30, 2019
84 FR 71812, 12/30/2019