H.R. 2427
Referred to CommitteeTo amend the Federal Food, Drug, and Cosmetic Act with respect to advisory committee process.
Latest Action
Referred to the Subcommittee on Health.
5/22/2015 • House
Summary
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to provide an opportunity for a person whose premarket submission for a medical device is subject to review by a classification panel to provide recommendations on the expertise needed among the members of the panel.
The FDA must consider these recommendations and ensure that panels include at least two members with expertise clinically relevant to the device and at least one member who is knowledgeable about the technology of the device.
The person whose device is under review may designate a representative (who may be accompanied by experts) to participate in panel meetings.Introduced in House • 5/19/2015
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Bill Journey
Originated in the House
Introduced
May 19, 2015
Referred to the House Committee on Energy and Commerce.
Committee Review
Floor Debate
Passed Chamber
Other Chamber
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Enacted into Law