H.R. 3208 – Patients Come First Act of 2011
LEGISLATIVE INFORMATION PAGE
Bill Number: H.R. 3208
CHI Position: Support
Title: Patients Come First Act of 2011
Primary Sponsor: Shimkus (R-IL) 11 Co-sponsors
Introduced: 10/14/10: Referred to House Energy and Commerce
The Act reaffirms the mandates of the Safe Medical Devices Act of 1990 that required the FDA to either reclassify preamendment class III devices to a lower class, or force them to go through the premarket approval process.
The act also codifies GAO’s recommendations that Congress reform FDA’s current device recall authority which call for the FDA Secretary to:
- Establish a program to routinely and systematically assess information relating to device recalls and use such information to proactively identify strategies for mitigating health risks presented by defective or unsafe devices.
- Program to include
- Trends in the number and types of device recalls;
- Devices that are more frequently the subject of a recall; and
- Underlying causes of device recalls.
- Clarify procedures for conducting device recall audit checks to improve the ability of investigators to perform those checks in a consistent manner;
- Develop detailed criteria for assessing whether a person performing a device recall has performed an effective correction or action plan for the recall; and
- Document the basis for each termination by the FDA of a device recall.
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California Delegation Co-Sponsors: