To amend the Federal Food, Drug, and Cosmetic Act to provide an alternative standard for substantial equivalence determinations for devices, and for other purposes.
Health Subcommittee, Energy and Commerce Committee
Introduced
In Committee
On Floor
Passed Chamber
Enacted
Medical Product Review Harmonization Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to establish an alternative standard for demonstrating a device's substantial equivalence to a medical device that has already been approved by the Food and Drug Administration.
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Timeline
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Health
Drug safety, medical device, and laboratory regulationHealth technology, devices, suppliesPublic participation and lobbying
To amend the Federal Food, Drug, and Cosmetic Act to provide an alternative standard for substantial equivalence determinations for devices, and for other purposes.
USA115th CongressHR-2474| House
| Updated: 5/19/2017
Medical Product Review Harmonization Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to establish an alternative standard for demonstrating a device's substantial equivalence to a medical device that has already been approved by the Food and Drug Administration.