US Congress House Bill 2427 (Prior Session Legislation)

---

Spectrum: Partisan Bill (Republican 1-0)
Status: Introduced on May 19 2015 - 25% progression, died in committee
Action: 2015-05-22 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]

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.

To amend the Federal Food, Drug, and Cosmetic Act with respect to advisory committee process.

Rep. John Shimkus [R-IL]

Date	Chamber	Action
2015-05-22	House	Referred to the Subcommittee on Health.
2015-05-19	House	Referred to the House Committee on Energy and Commerce.
2015-05-19	House	Introduced in House

HB6 (Related) 2015-07-13 - Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
SB2737 (Related) 2016-03-17 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Type	Source
Summary	https://www.congress.gov/bill/114th-congress/house-bill/2427/all-info
Text	https://www.congress.gov/114/bills/hr2427/BILLS-114hr2427ih.pdf