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S.1700 - Medical Device Regulatory Improvement Act
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.
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Ms. KLOBUCHAR (for herself, Mr. BURR, and Mr. BENNET) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and PensionsCommentsClose CommentsPermalink
SECTION 1. SHORT TITLE.
SEC. 2. CLARIFICATION OF LEAST BURDENSOME.
‘(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;CommentsClose CommentsPermalink
‘(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;CommentsClose CommentsPermalink
‘(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; andCommentsClose CommentsPermalink
SEC. 3. CONFLICTS OF INTEREST.
‘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.’.CommentsClose CommentsPermalink
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).CommentsClose CommentsPermalink
(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.CommentsClose CommentsPermalink
(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).CommentsClose CommentsPermalink