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FDA legislation related to reform of the approval process for medical devices.
H.R. 3211: Humanitarian Device Reform Act of 2011.

Implementation of the Physician Sunshine Act. H.R. 3209 - Premarket Predictability Act of 2011 - Provisions relating to a new streamlined review of new devices, require reviewers to provide scientific or regulatory rationale for major decisions and establish an expedited approval appellate process, and the establishment of the two Investigational Device Exemption pathways.

H.R. 3203 - Novel Device Regulatory Relief Act of 2011 - Streamlines the de novo classification process by striking the requirement that an applicant submit a 510(k) application before entering the de novo process.

H.R. 3206 - Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011 - Fixes the FDA's conflict of interest policies to ensure the most knowledgeable experts are able to serve on FDA advisory committees.  

H.R. 3214 - Food and Drug Amdinistration Mission Reform Act of 2011 - establishes a regulatory system that is accessible, consistent and transparent, promotes predictability, allows flexibility and reduces uncertainty, facilitates innovation, protects public health and enables patients accessto novel products, and incorporates a patient-focused, risk-benefit framework to ensure the FDA takes them into account.

H.R. 3205 - FDA Renewing Efficiency From Outside Reviewer Management Act of 2011 - Reauthorizes the third party inspection program and reforms the third party review program to foster better participation, decrease approval times and conserve FDA resources.
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