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To amend the Federal Food, Drug, and Cosmetic Act with respect to advisory committee process.
1/11/2023, 1:31 PM
Congressional Summary of HR 2427
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.Read the Full Bill
Current Status of Bill HR 2427
Bill HR 2427 is currently in the status of Bill Introduced since May 19, 2015. Bill HR 2427 was introduced during Congress 114 and was introduced to the House on May 19, 2015. Bill HR 2427's most recent activity was Referred to the Subcommittee on Health. as of May 22, 2015
Bipartisan Support of Bill HR 2427
Total Number of Sponsors
1Democrat Sponsors
0Republican Sponsors
1Unaffiliated Sponsors
0Total Number of Cosponsors
0Democrat Cosponsors
0Republican Cosponsors
0Unaffiliated Cosponsors
0Policy Area and Potential Impact of Bill HR 2427
Primary Policy Focus
HealthPotential Impact Areas
- Advisory bodies
- Drug safety, medical device, and laboratory regulation
- Health technology, devices, supplies
- Product safety and quality
Alternate Title(s) of Bill HR 2427
To amend the Federal Food, Drug, and Cosmetic Act with respect to advisory committee process.
To amend the Federal Food, Drug, and Cosmetic Act with respect to advisory committee process.
Comments
Sponsors and Cosponsors of HR 2427
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