Code of Federal Regulations · Section
§ 898.13 — Compliance Dates
21 C.F.R. § 898.13
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The dates for compliance with the standard set forth in § 898.12(a) shall be as follows:
(a) For electrode lead wires and patient cables used with, or intended for use with, the following devices, the date for which compliance is required is May 11, 1998:
Listing of Devices for Which Compliance is Required Effective
May 11, 1998
(b) For electrode lead wires and patient cables used with, or intended for use with, any other device, the date for which compliance is required is May 9, 2000.
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