21 CFR 898.11
§ 898.11 Applicability.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 898.11, § 898.11 Applicability, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91365
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Full text
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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.