H.R. 2427 · 114th Congress
To amend the Federal Food, Drug, and Cosmetic Act with respect to advisory committee process.
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Never voted on. It didn't reach a floor vote before the 114th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
R
ShimkusSponsorNo cosponsors.
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.
What it does: CRS summary · Introduced in House · May 19, 2015
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.Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: To amend the Federal Food, Drug, and Cosmetic Act with respect to advisory committee process.
Latest action (May 22, 2015): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: May 19, 2015
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.