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H.R. 3209: Premarket Predictability Act of 2011

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H.R. 3209: Premarket Predictability Act of 2011

112th Congress · introduced 2011-10-14 · Health · Latest: Referred to the Subcommittee on Health.

federal

Follow this bill, step by step

  1. Where it came from: introduced 2011-10-14 · official record
  2. Who proposed it: Rep. Shimkus, John [R-IL-19] · what a sponsor is
  3. What happened next: no floor votes in our records yet. Why?
  4. Where it stands now: Referred to the Subcommittee on Health. 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

Premarket Predictability Act of 2011

Plain summary

Premarket Predictability Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to assign a tracking number to a medical device upon submission of: (1) an application for an exemption of a device for investigational use, (2) a request to classify a device, or (3) a premarket report or notification related to a device. Requires the Secretary to use the tracking number to record interactions between the Secretary and applicant with respect to the device. Directs the Secretary to: (1) assign a reviewer with prior review experience with the type of of device or technology involved or other relevant expertise to review an application for an exemption of a device for investigational use, and (2) evaluate whether the investigational study can be conducted ethically with reasonable risk in determining whether to grant an exemption for investigational use. Prohibits the Secretary from disapproving an application because the investigation does not or may not meet any requirement relating to the approval or clearance of a device because the Secretary believes that a different clinical testing design or plan could produce data more relevant to an approval or clearance decision. Revises the procedures relating to submission of an application to investigate a class II or a class III device, which may include a plan for determining whether the device is substantially equivalent to or is at least as safe and effective as a legally marketed device that is not subject to premarket approval requirements. Sets forth requirements for the Secretary to meet in determining the least burdensome appropriate means of evaluating medical device effectiveness that would have a reasonable likelihood of resulting in approval. Requires the Secretary to document the scientific and regulatory rationale for any significant decision of the Center for Devices and Radiological Health regarding device review, approval, or exemption. Sets forth appeal procedures. Requires the Secretary to regularly publish detailed decision summaries for each clearance of a device not requiring premarket approval.

Congressional Research Service summary (Introduced in House), 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

Premarket Predictability Act of 2011

Source: Congressional Research Service summary (Introduced in House)

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The strongest published arguments

Arguments for (supporters)

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Arguments against (opponents)

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Alternatives

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

Officials and money

Sponsor: Rep. Shimkus, John [R-IL-19] · 20 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

Brett Guthrie (R-KY), Marsha Blackburn (R-TN), Bill Cassidy (R-LA), Robert E. Latta (R-OH)

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.

Words on this page, explained (2)
Appropriation
Money a legislature sets aside by law for a specific purpose. Government agencies may spend public money only as it has been appropriated.
Exemption
A rule that removes certain people, property or activities from a tax or requirement.

Plain meanings written from linked sources. All words.

Sources

Record fed-us-cong112-hr3209 · catalog fed-us-congress-bills-cong112 · updated 2026-11-15 by psicol fed-bills-cong112