EVALUATION OF AUTOMATIC CLASS III DESIGNATION.

SEC. 207. EVALUATION OF AUTOMATIC CLASS III 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) Any 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). “(C) Within 30 days after the issuance of an order classifying a device under this paragraph, the Secretary shall publish a notice in the Federal Register announcing such classification.”.