Page:United States Statutes at Large Volume 111 Part 3.djvu/252

 Ill STAT. 2340 PUBLIC LAW 105-115—NOV. 21, 1997 (2) by adding at the end the following: "(F) Not later than 270 days after the date of the enactment of the Food and Drug Administration Modernization Act of 1997, the Secretary shall issue guidance specifying the general principles that the Secretary will consider in determining when a specific intended use of a device is not reasonably included within a general use of such device for purposes of a determination of substantial equivalence under subsection (f) or section 520(1).". SEC. 207. EVALUATION OF AUTOMATIC CLASS in DESIGNATION. Section 513(f) (21 U.S.C. 360c(f)), as amended by section 206(b), is amended— (1) in paragraph (1)— (A) in subparagraph (B), by striking "paragraph (2)" and inserting "paragraph (3)"; and (B) in the last sentence, by striking "paragraph (2)" and inserting "paragraph (2) or (3)"; (2) by redesignating paragraphs (2) and (3) as paragraphs (3) and (4), respectively; and (3) by inserting after paragraph (1) the following: "(2)(A) Aiy person who submits a report under section 510(k) for a type of device that has not been previously classified under this Act, and that is classified into class III under paragraph (1), may request, within 30 days after receiving written notice of such a classification, the Secretary to classify the device under the criteria set forth in subparagraphs (A) through (C) of subsection (a)(1). The person may, in the request, recommend to the Secretary a classification for the device. Any such request shall describe the device and provide detailed information and reasons for the recommended classification. "(B)(i) Not later than 60 days after the date of the submission of the request under subparagraph (A), the Secretary shall by written order classify the device involved. Such classification shall be the initial classification of the device for purposes of paragraph (1) and any device classified under this paragraph shall be a predicate device for determining substantial equivalence under paragraph (1). "(ii) A device that remains in class III under this subparagraph shall be deemed to be adulterated within the meaning of section 501(f)(1)(B) until approved under section 515 or exempted from such approval under section 520(g). Federal Register, "(C) Within 30 days after the issuance of an order classifying publication. a device under this paragraph, the Secretary shall publish a notice in the Federal Register announcing such classification.". SEC. 208. CLASSIFICATION PANELS. Section 513(b) (21 U.S.C. 360c(b)) is amended by adding at the end the following: "(5) Classification panels covering each t3rpe of device shall be scheduled to meet at such times as may be appropriate for the Secretary to meet applicable statutory deadlines. "(6)(A) Any person whose device is specifically the subject of review by a classification panel shall have— "(i) the same access to data and information submitted to a classification panel (except for data and information that are not available for public disclosure under section 552 of title 5, United States Code) as the Secretary;

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