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H.R. 3205: FDA Renewing Efficiency From Outside Reviewer Management Act of 2011

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H.R. 3205: FDA Renewing Efficiency From Outside Reviewer Management 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. Paulsen, Erik [R-MN-3] · 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

FDA Renewing Efficiency From Outside Reviewer Management Act of 2011

Plain summary

FDA Renewing Efficiency From Outside Reviewer Management Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to revise and extend through October 1, 2017, provisions authorizing accredited persons to provide classification reports for a medical device and to inspect class II device or class III device facilities. Deems a recommendation of an accredited person as to the classification of a medical device to be accepted by the Secretary of Health and Human Services (HHS) if the Secretary fails to make a determination with respect to the recommendation within 30 days. Requires the Secretary to regularly publish: (1) detailed decision summaries for each clearance of a device, classification of a device, approval of an application of a device, or grant of exemption for a device occurring after the enactment of this Act; and (2) total product life cycles information for devices. Expands the devices for which an accredited person may perform a review to include: (1) a class II device for which clinical data is required in the report, and (2) a class II device which is intended to be permanently implantable or life sustaining or supporting only if notification is provided to the Secretary before such a review. Deems the review permissible if the Secretary does not object within 60 days. Requires the Secretary to provide for the initial training and periodic updating of training of accredited persons. Makes accreditation valid for three years. Sets forth provisions regarding reaccreditation. Prohibits an accredited person from being a sole practitioner. Provides that the prohibitions against an accredited person being owned or controlled by a manufacturer, supplier, or vendor of devices or engaging in the design, manufacture, promotion, or sale of devices shall apply only if the devices are of the same type for which the person is accredited.

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

FDA Renewing Efficiency From Outside Reviewer Management 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. Paulsen, Erik [R-MN-3] · 16 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

Brett Guthrie (R-KY), Bill Cassidy (R-LA), Marsha Blackburn (R-TN), 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 (1)
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-hr3205 · catalog fed-us-congress-bills-cong112 · updated 2026-11-15 by psicol fed-bills-cong112