Sec. 619. GOOD GUIDANCE PRACTICES RELATING TO DEVICES

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## SEC. 619 GOOD GUIDANCE PRACTICES RELATING TO DEVICES Subparagraph

(C)of section 701(h)(1) (21 U.S.C. 371(h)(1)) is amended— ####

(1)by striking “(C) For guidance documents” and inserting “(C)(i) For guidance documents”; and ####

(2)by adding at the end the following: > > ###### “(ii) > > With respect to devices, if a notice to industry guidance letter, a notice to industry advisory letter, or any similar notice sets forth initial interpretations of a regulation or policy or sets forth changes in interpretation or policy, such notice shall be treated as a guidance document for purposes of this subparagraph.” > .

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U.S. Code

Regulations and hearings
§ 371

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Sec. 619

GOOD GUIDANCE PRACTICES RELATING TO DEVICES

U.S.C.§ 371

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