GOOD GUIDANCE PRACTICES RELATING TO DEVICES.

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.” .