21 CFR 878.4100 - Organ bag.

Regulations last checked for updates: Oct 17, 2024

Title 21 - Food and Drugs last revised: Oct 15, 2024

View all text of Subpart E [§ 878.4010 - § 878.5050]

§ 878.4100 - Organ bag.

(a) Identification. An organ bag is a device that is a flexible plastic bag intended to be used as a temporary receptacle for an organ during surgical procedures to prevent moisture loss.

(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 § 878.9.

[53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 65 FR 2318, Jan. 14, 2000]

authority: 21 U.S.C. 351,360,360c,360e,360j,360l,371

source: 53 FR 23872, June 24, 1988, unless otherwise noted.

cite as: 21 CFR 878.4100