S. 1700: Medical Device Regulatory Improvement Act

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S. 1700: Medical Device Regulatory Improvement Act

112th Congress · introduced 2011-10-13 · Health · Latest: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

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Official title

Medical Device Regulatory Improvement Act

Plain 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.

Congressional Research Service summary (Introduced in Senate), quoted unchanged (nonpartisan). Read the source.

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Officials and money

Sponsor: Sen. Klobuchar, Amy [D-MN] · 3 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

Michael F. Bennet (D-CO)

Sponsor's campaign money: Sen. Klobuchar, Amy [D-MN] reported raising $2.5 million (2025–2026). Details. Shown for context only; it does not mean any donor supported this bill.

No linked floor roll calls in our collected records yet. This does not mean the bill has never had a vote. Check the official bill history.

Sources

• Congressional Research Service summary (Introduced in Senate)
• Congress.gov
• Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-112s1700.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/112/s>

Record fed-us-cong112-s1700 · catalog fed-us-congress-bills-cong112 · updated 2026-11-15 by psicol fed-bills-cong112