US Congress House Bill 2425 (Prior Session Legislation)

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Sponsorship: Partisan Bill (Republican 1)
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 the recognition of standards. This bill amends the Federal Food, Drug, and Cosmetic Act to allow a person to request that the Food and Drug Administration (FDA) recognize all or part of a performance standard established by a nationally or internationally recognized standard organization as a standard to which a medical device may conform in order to meet an FDA requirement. When a request to recognize a standard is received, the FDA must determine whether to recognize all, part, or none of the standard and publish the rationale for that determination. (Currently, the FDA recognizes certain performance standards, but it is not required to respond to requests or publish rationales for recognizing standards.) The FDA must: (1) publish the rationale for recognizing only part of a standard, (2) periodically train employees who review premarket submissions for medical devices on the concept and use of recognized standards for purposes of meeting requirements, and (3) publish its principles for recognizing standards.

To amend the Federal Food, Drug, and Cosmetic Act with respect to the recognition of standards.

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/2425/all-info
Text	https://www.congress.gov/114/bills/hr2425/BILLS-114hr2425ih.pdf