A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to medical device regulation, and for other purposes.

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Safe, Efficient, 
and Transparent Medical Device Approval Act'' or the ``SET Device 
Act''.
    (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Sec. 3. Establishment of schedule and promulgation of regulation.
Sec. 4. Modification of de novo application process.

SEC. 2. FINDINGS.

    Congress finds as follows:
            (1) Under the Safe Medical Devices Act of 1990 (Public Law 
        101-629), Congress amended section 515 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 360e) to require the Food and 
        Drug Administration to reclassify preamendment class III 
        devices to a lower class or to require them to go through the 
        premarket approval process.
            (2) The Food and Drug Administration has not yet complied 
        with the mandate of Congress under such Act.
            (3) The de novo process, created by the Food and Drug 
        Administration Modernization Act of 1997 (Public Law 105-115), 
        is an approval mechanism by which the Food and Drug 
        Administration may down-classify, to class I or class II, 
        devices that have no predicates and thus are designated class 
        III, but are deemed to be of low to moderate risk. The process 
        avoids having novel, low- to moderate-risk devices go through 
        the premarket approval process. Under the current de novo 
        process, the manufacturer must first make a submission under 
        section 510(k) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 360), even if no known predicate device exists. A 2011 
        Institute of Medicine report found that, between 2005 and 2009, 
        review times for novel therapeutic devices through the de novo 
        process nearly tripled. The report concluded that the current 
        de novo process has not met its potential as an alternative 
        regulatory pathway, and recommended the establishment of a 
        modified de novo process.

SEC. 3. ESTABLISHMENT OF SCHEDULE AND PROMULGATION OF REGULATION.

    (a) Establishment of Schedule.--Not later than 120 days after the 
date of enactment of this Act, the Secretary of Health and Human 
Services (referred to in this section as the ``Secretary''), shall 
establish the schedule referred to in section 515(i)(3) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360e(i)(3)) for each device 
that the Secretary requires to remain in class III through a 
determination under section 515(i)(2) of such Act.
    (b) Action Regarding Class II and III.--Not later than 18 months 
after the date of enactment of this Act, the Secretary shall--
            (1) issue a final regulation under section 515(b) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(b)) for 
        each device that the Secretary requires to remain in class III 
        through a determination under section 515(i)(2) of such Act; 
        and
            (2) establish the special controls required by section 
        513(a)(1)(B) of such Act (21 U.S.C. 360c(a)(1)(B)) for each 
        device that is classified into class II pursuant to a 
        determination revising the classification of the device under 
        section 515(i)(2) of such Act.

SEC. 4. MODIFICATION OF DE NOVO APPLICATION PROCESS.

    (a) In General.--Section 513(f)(2) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360c(f)(2)) is amended--
            (1) by redesignating subparagraphs (B) and (C) as 
        subparagraphs (C) and (D), respectively;
            (2) by amending subparagraph (A) to read as follows:
    ``(A) In the case of a type of device that has not previously been 
classified under this Act, a person may do one of the following:
            ``(i) Submit a report under section 510(k), and, if the 
        device is classified into class III under paragraph (1), such 
        person may request, not later than 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.
            ``(ii) Submit a request for initial classification of the 
        device under this subparagraph, if the person declares that 
        there is no legally marketed device upon which to base a 
        substantial equivalence determination as that term is defined 
        in section 513(i). Subject to subparagraph (B), the Secretary 
        shall classify the device under the criteria set forth in 
        subparagraphs (A) through (C) of subsection (a)(1). The person 
        submitting the request for classification under this 
        subparagraph may recommend to the Secretary a classification 
        for the device and shall 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.'';
            (3) by inserting after subparagraph (A) the following:
    ``(B) The Secretary may decline to undertake a classification 
request submitted under clause (2)(A)(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.''; and
            (4) in subparagraph (C), as so redesignated--
                    (A) in clause (i), by striking ``Not later than 60 
                days after the date of the submission of the request 
                under subparagraph (A),'' and inserting ``Not later 
                than 90 days after the date of the submission of the 
                request under subparagraph (A)(i) or 120 days after the 
                date of the submission of the request under 
                subparagraph (A)(ii),''; and
                    (B) in clause (ii), by inserting ``or is classified 
                in'' after ``remains in''.
    (b) GAO Report.--Not later than 2 years after the date of enactment 
of this Act, the Comptroller General of the United States shall 
complete a study and submit to Congress a report on the effectiveness 
of the review pathway under section 513(f)(2)(A) of the Federal Food, 
Drug, and Cosmetic Act, as amended by this Act.
    (c) Conforming Amendment.--Section 513(f)(1)(B) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360c(f)(1)(B)) is amended by 
inserting ``a request under paragraph (2) or'' after ``response to''.

Summary: Safe, Efficient, and Transparent Medical Device Approval Act or the SET Device Act - Directs the Secretary of Health and Human Services (HHS), within 120 days of enactment of this Act, to establish the schedule for the promulgation of a regulation requiring premarket approval for a medical device that the Secretary requires to remain in class III.

Directs the Secretary, within 18 months, to: (1) issue a final regulation for each device that the Secretary requires to remain in class III, and (2) establish the required special controls for each device that is classified into class II pursuant to a determination revising such devise's classification.

Amends the Federal Food, Drug, and Cosmetic Act to permit a person to: (1) submit a request for initial classification of a device that has not previously been classified under such Act if the person declares that there is no legally marketed device upon which to base a substantial equivalence determination; and (2) recommend to the Secretary a classification for the device and include in the request an initial draft proposal for applicable special and general controls that are necessary to provide reasonable assurance of safety and effectiveness.

Permits the Secretary to decline to undertake a classification request if the Secretary identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence or if the Secretary determines that the device submitted is not of low-moderate risk.