A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to device review determinations and conflicts of interest, and for other purposes.

Summary: Medical Device Regulatory Improvement Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS), in determining the least burdensome appropriate means of evaluating device effectiveness, to: (1) not request information unrelated or irrelevant to demonstration of reasonable assurance of device safety and effectiveness; (2) consider alternative approaches to evaluating device safety and effectiveness; (3) use all reasonable mechanisms to lessen review times and render regulatory decisions; (4) determine whether pre-clinical data can meet the statutory threshold for approval; and (5) utilize, whenever practicable, alternatives to randomized, controlled clinical trials if clinical data are needed.

Requires the Secretary, in determining the least burdensome means of determining substantial equivalence, to: (1) focus on whether the device has the same intended use as the predicate device and is as safe and effective as a legally marketed device, (2) not request or accept information unrelated or irrelevant to the substantial equivalence evaluation, (3) review the labeling of the device to assess the intended use of the device and not evaluate issues that do not present a major impact on the intended use as set forth in the labeling, (4) consider alternative approaches to evaluating substantial equivalence, and (5) use all reasonable mechanisms to lessen review times and render regulatory decisions.

Repeals conflict-of-interest provisions that are specific to the Food and Drug Administration (FDA) and provides for the continued applicability of conflict-of-interest provisions otherwise applicable to advisory committees, federal employees, and special government employees.

Requires the Secretary to contract with an eligible entity for a review of the management and regulatory processes at the Center for Devices and Radiological Health.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Medical Device Regulatory 
Improvement Act''.

SEC. 2. CLARIFICATION OF LEAST BURDENSOME.

    (a) Premarket Approval.--Section 513(a)(3)(D) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360c(a)(3)(D)) is amended--
            (1) by redesignating clause (iii) as clause (iv); and
            (2) by inserting after clause (ii) the following:
    ``(iii) In carrying out clause (ii), the Secretary--
            ``(I) shall not request information unrelated or irrelevant 
        to a demonstration of reasonable assurance of device safety and 
        effectiveness;
            ``(II) shall consider alternative approaches to evaluating 
        device safety and effectiveness in order to reduce the time, 
        effort, and cost of reaching proper resolution of the issue;
            ``(III) shall use all reasonable mechanisms to lessen 
        review times and render regulatory decisions;
            ``(IV) shall determine whether pre-clinical data, such as 
        well-designed bench and animal testing, can meet the statutory 
        threshold for approval; and
            ``(V) if clinical data are needed, shall utilize, whenever 
        practicable, alternatives to randomized, controlled clinical 
        trials, such as the use of surrogate endpoints.''.
    (b) Substantial Equivalence Determination.--Section 513(i)(1)(D) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(i)(1)(D)) is 
amended--
            (1) by striking ``(D) Whenever'' and inserting ``(D)(i) 
        Whenever''; and
            (2) by adding at the end the following:
    ``(ii) In carrying out clause (i), the Secretary--
            ``(I) shall focus on whether the device has the same 
        intended use as the predicate device and is as safe and 
        effective as a legally marketed device;
            ``(II) shall not request or accept information unrelated or 
        irrelevant to the substantial equivalence evaluation;
            ``(III) shall review the labeling of the device to assess 
        the intended use of the device, and shall not evaluate issues 
        that do not present a major impact on the intended use as set 
        forth in the labeling;
            ``(IV) shall consider alternative approaches to evaluating 
        substantial equivalence in order to reduce the time, effort, 
        and cost of reaching proper resolution of the issue; and
            ``(V) shall use all reasonable mechanisms to lessen review 
        times and render regulatory decisions.''.

SEC. 3. CONFLICTS OF INTEREST.

    Section 712 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379d-1) is amended to read as follows:

``SEC. 712. CONFLICTS OF INTEREST.

    ``Except as otherwise provided in this Act, each advisory committee 
under the Federal Advisory Committee Act that provides advice or 
recommendations to the Secretary regarding activities of the Food and 
Drug Administration is subject to the provisions in such Act and the 
members of each such committee are subject to the provisions regarding 
Federal employees and special Government employees, as applicable, in 
title I of the Ethics in Government Act of 1978 and section 208 of 
title 18, United States Code.''.

SEC. 4. MANAGEMENT AND INNOVATION REVIEW.

    (a) In General.--Not later than 60 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 enter into a contract with an 
eligible entity to carry out the activities described in subsection 
(c).
    (b) Eligible Entity.--To be eligible to enter into a contract with 
the Secretary under subsection (a), an entity shall--
            (1) be an entity with experience in evaluating the 
        management and operating structure of large organizations; and
            (2) submit to the Secretary an application at such time, in 
        such manner, and containing such information as the Secretary 
        may require.
    (c) Activities.--The entity with which the Secretary enters into 
the contract under subsection (a) shall, pursuant to such contract, 
conduct an extensive review of the management and regulatory processes 
at the Center for Devices and Radiological Health of the Food and Drug 
Administration to ensure any actions carried out by such Center take 
into consideration the potential impacts on innovation with respect to 
medical devices and other products regulated by such Center.
    (d) Report.--Not later than 1 year after the date that the 
Secretary enters into the contract with the eligible entity under 
subsection (a), such entity shall submit to Congress and the Secretary 
a report that describes the findings and recommendations of such entity 
based on the review conducted under subsection (c).
    (e) Funding.--To carry out this section, the Secretary shall use 
funds otherwise available for the operation of the Office of the 
Secretary.