21 CFR 898.11 - Applicability.

Regulations last checked for updates: Apr 30, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025

§ 898.11 - Applicability.

Electrode lead wires and patient cables intended for use with a medical device shall be subject to the performance standard set forth in § 898.12.

authority: 21 U.S.C. 351,352,360c,360d,360gg,371,374; 42 U.S.C. 262,264

source: 62 FR 25497, May 9, 1997, unless otherwise noted.

cite as: 21 CFR 898.11