HR 3208 — Patients Come First Act of 2011

1 sponsors · 0 co-sponsors · 546 not signed on

"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.

Frequently asked questions

What does HR 3208 do?

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.

Who sponsors HR 3208?

HR 3208 is sponsored by John Shimkus (R).

What is the current status of HR 3208?

This bill died with 112th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.

Where can I track HR 3208?

Track HR 3208 free on One Click Politics — get push/email alerts when it moves.