MODIFICATION OF DE NOVO APPLICATION PROCESS.

SEC. 607. MODIFICATION OF DE NOVO APPLICATION PROCESS. (a) In General.—Section 513(f)(2) (21 U.S.C. 360c(f)(2)) is amended— (1) by inserting “(i)” after “(2)(A)”; (2) in subparagraph (A)(i), as so designated by paragraph (1), by striking “under the criteria set forth” and all that follows through the end of subparagraph (A) and inserting a period; (3) by adding at the end of subparagraph (A) the following: “(ii) In lieu of submitting a report under section 510(k) and submitting a request for classification under clause (i) for a device, if a person determines there is no legally marketed device upon which to base a determination of substantial equivalence (as defined in subsection (i)), a person may submit a request under this clause for the Secretary to classify the device. “(iii) Upon receipt of a request under clause (i) or (ii), the Secretary shall classify the device subject to the request under the criteria set forth in subparagraphs (A) through (C) of subsection (a)(1) within 120 days. “(iv) Notwithstanding clause (iii), the Secretary may decline to undertake a classification request submitted under clause (ii) if the Secretary identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence under paragraph (1), or when the Secretary determines that the device submitted is not of low-moderate risk or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed. “(v) The person submitting the request for classification under this subparagraph may recommend to the Secretary a classification for the device and shall, if recommending classification in class II, include in the request an initial draft proposal for applicable special controls, as described in subsection (a)(1)(B), that are necessary, in conjunction with general controls, to provide reasonable assurance of safety and effectiveness and a description of how the special controls provide such assurance. Any such request shall describe the device and provide detailed information and reasons for the recommended classification.” ; and (4) in subparagraph (B), by striking “Not later than 60 days after the date of the submission of the request under subparagraph (A), the Secretary” and inserting “The Secretary”. (b) Conforming Amendments.—Section 513(f) (21 U.S.C. 360c(f)) is amended in paragraph (1)— (1) in subparagraph (A), by striking “, or” at the end and inserting a semicolon; (2) in subparagraph (B), by striking the period and inserting “; or”; and (3) by inserting after subparagraph (B) the following: “(C) the device is classified pursuant to a request submitted under paragraph (2).” .