H.R. 3209 (112th): Premarket Predictability Act of 2011

Oct 14, 2011 (112th Congress, 2011–2013)
Died (Referred to Committee)
John Shimkus
Representative for Illinois's 19th congressional district
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Last Updated
Oct 14, 2011
12 pages

This bill was introduced on October 14, 2011, in a previous session of Congress, but was not enacted.

Introduced Oct 14, 2011
Referred to Committee Oct 14, 2011
Full Title

To amend the Federal Food, Drug, and Cosmetic Act to provide predictability, consistency, and transparency to the premarket review process.


No summaries available.

20 cosponsors (18R, 2D) (show)

House Energy and Commerce


The committee chair determines whether a bill will move past the committee stage.

Primary Source

THOMAS.gov (The Library of Congress)

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H.R. stands for House of Representatives bill.

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The bill’s title was written by its sponsor.

GovTrack’s Bill Summary

We don’t have a summary available yet.

Library of Congress Summary

The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress.

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.

House Republican Conference Summary

The summary below was written by the House Republican Conference, which is the caucus of Republicans in the House of Representatives.

No summary available.

House Democratic Caucus Summary

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