Code of Federal Regulations · Section
§ 898.11 — Applicability
21 C.F.R. § 898.11
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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.
Authorizing Statute
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Regulation of biological products42 U.S.C. § 262
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Adulterated drugs and devices21 U.S.C. § 351