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Titles Actions Overview All Actions Cosponsors Committees Related Bills Subjects Latest Summary All Summaries

Titles (2)

Short Titles

Short Titles - House of Representatives

Short Titles as Introduced

Patients Come First Act of 2011

Official Titles

Official Titles - House of Representatives

Official Title as Introduced

To reaffirm the Safe Medical Devices Act of 1990 by requiring that the Secretary of Health and Human Services establish a schedule and issue regulations as required under section 515(i) of the Federal Food, Drug, and Cosmetic Act, and for other purposes.

Actions Overview (1)

10/14/2011Introduced in House

All Actions (3)

10/18/2011Referred to the Subcommittee on Health.
Action By: Committee on Energy and Commerce
10/14/2011Referred to the House Committee on Energy and Commerce.
Action By: House of Representatives
10/14/2011Introduced in House
Action By: House of Representatives

Committees (1)

Committees, subcommittees and links to reports associated with this bill are listed here, as well as the nature and date of committee activity and Congressional report number.

Committee / Subcommittee Date Activity Reports
House Energy and Commerce10/14/2011 Referred to
House Energy and Commerce Subcommittee on Health10/18/2011 Referred to

No related bill information was received for H.R.3208.

Latest Summary (1)

There is one summary for H.R.3208. View summaries

Shown Here:
Introduced in House (10/14/2011)

Patients Come First Act of 2011 - Directs the Secretary of Health and Human Services (HHS): (1) within 90 days after enactment of this Act, to establish the schedule required under the Federal Food, Drug, and Cosmetic Act for the promulgation of regulations requiring premarket approval for medical devices required to remain in class III; and (2) not later than one year after the schedule is established, to issue a final regulation for each such device.

Directs the Secretary to: (1) establish a program to assess information relating to device recalls and use such information to proactively identify strategies for mitigating health risks presented by defective or unsafe devices, (2) clarify procedures for conducting device recall audit checks to improve the ability of investigators to perform those checks in a consistent manner, (3) develop detailed criteria for assessing whether a person performing a device recall has performed an effective correction or action plan for the recall, and (4) document the basis for each Food and Drug Administration (FDA) termination of a device recall.