21 CFR 820.130 - Device packaging.

Regulations last checked for updates: May 23, 2025

Title 21 - Food and Drugs last revised: May 19, 2025

View all text of Subpart K [§ 820.120 - § 820.130]

§ 820.130 - Device packaging.

Each manufacturer shall ensure that device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution.

authority: 21 U.S.C. 351,352,360,360c,360d,360e,360h,360i,360j,360l,371,374,381,383; 42 U.S.C. 216,262,263a,264

source: 61 FR 52654, Oct. 7, 1996, unless otherwise noted.

cite as: 21 CFR 820.130