Bill
Bill > HR2427
US HR2427
To amend the Federal Food, Drug, and Cosmetic Act with respect to advisory committee process.
summary
Introduced
05/19/2015
05/19/2015
In Committee
05/22/2015
05/22/2015
Crossed Over
Passed
Dead
01/03/2017
01/03/2017
Introduced Session
114th Congress
Bill Summary
To amend the Federal Food, Drug, and Cosmetic Act with respect to advisory committee process. 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.
Committee Categories
Business and Industry, Health and Social Services
Sponsors (1)
Last Action
Referred to the Subcommittee on Health. (on 05/22/2015)
Official Document
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