PSI Sci
New here? Follow the money and the votes · Not sure of your district? Find your U.S. House member · Find your state legislators

S. 1995: Medical Device Patient Safety Act

Before you vote › Federal bills

S. 1995: Medical Device Patient Safety Act

112th Congress · introduced 2011-12-14 · Health · Latest: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

federal

Follow this bill, step by step

  1. Where it came from: introduced 2011-12-14 · official record
  2. Who proposed it: Sen. Grassley, Chuck [R-IA] · what a sponsor is
  3. What happened next: no floor votes in our records yet. Why?
  4. Where it stands now: Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Not final yet: this can still change. We check for updates every day.
  5. If it becomes law and spends money: follow the money to money laws, then agencies and contracts and grants.

What does this mean?

Official title

Medical Device Patient Safety Act

Plain summary

Medical Device Patient Safety Act - Directs the Secretary of Health and Human Services (HHS), acting through the Commissioner of Food and Drugs, to establish a program to enhance the oversight by the Food and Drug Administration (FDA) of medical device recalls. Requires the program to routinely and systematically assess: (1) information submitted to the Secretary pursuant to a device recall order issued under the Federal Food, Drug, and Cosmetic Act (FDCA); and (2) information required to be reported by a device manufacturer to the Secretary regarding the manufacturer's correction or removal of a device. Requires the Secretary to use such information to proactively identify strategies for mitigating health risks presented by defective or unsafe devices. Requires such program to be designed to identify such things as recall trends, the causes of recalls, and the time to complete a recall. Requires the Secretary to develop explicit criteria for assessing whether a person subject to a recall order or the manufacturer's reporting requirement has performed an effective correction or removal action. Requires the Secretary to document and publish specified information concerning termination of a recall. Permits the Secretary to conditionally clear for introduction into interstate commerce for commercial distribution a medical device intended for human use if such medical device is cleared pursuant to specified FDCA reporting requirements concerning the introduction of devices into interstate commerce. Permits the Secretary, as part of such conditional clearance, to: (1) impose specified restrictions on the sale, distribution, or use of the device; (2) require specified labeling for the device; and (3) require the maintenance of specified records that enable the FDA to track the device and determine the safety and effectiveness of the device.

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

What a vote does

A “Yea” vote

If it passes both chambers and is signed, it becomes law.

A “Nay” vote

If it is not passed, current law stays as it is.

PSI Sci description of the legislative step (not an opinion).

What does this mean? (plain words)

Official text

Medical Device Patient Safety Act

Source: Congressional Research Service summary (Introduced in Senate)

AI explanation – may be wrong, check the official text

No AI explanation yet. It takes up to a minute to write and is then saved for everyone.

Limited to a few requests an hour per person.

The strongest published arguments

Arguments for (supporters)

Needs sources: no published arguments on this side yet. We only show items backed by a published source. Suggest one.

Arguments against (opponents)

Needs sources: no published arguments on this side yet. We only show items backed by a published source. Suggest one.

Alternatives

Needs sources: no published alternatives yet (for example a different bill, a law instead of an amendment, or keeping current law). We only show items backed by a published source. Suggest one.

How did my representative vote? · This bill's floor votes

Officials and money

Sponsor: Sen. Grassley, Chuck [R-IA] · 2 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

Richard Blumenthal (D-CT)

Sponsor's campaign money: Sen. Grassley, Chuck [R-IA] reported raising $527,998 (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

Record fed-us-cong112-s1995 · catalog fed-us-congress-bills-cong112 · updated 2026-11-15 by psicol fed-bills-cong112