To amend the Federal Food, Drug, and Cosmetic Act with respect to advisory committee process.
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3d open
vs 6,526 other HR bills in the 114th — cohort avg 56d
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.
Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Congress.gov source codes: 1000, Intro-H
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Sources: Congress.gov