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
In Committee
05/22/2015
Crossed Over
Passed
Dead
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)

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