Health Subcommittee, Energy and Commerce Committee
Introduced
In Committee
On Floor
Passed Chamber
Enacted
Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2017 or the DEVICE Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to require medical device manufacturers to notify the Food and Drug Administration (FDA): (1) before making changes to the design or reprocessing instructions of a device, and (2) no more than five days after widely disseminating to health care providers in a foreign country communications regarding changes to the design or reprocessing instructions of a device or regarding a safety concern about a device. A device may not be sold if the manufacturer violates these notification requirements. Rapid assessment tests intended to ensure the proper reprocessing of reusable medical devices are defined as medical devices. The FDA must publish a list of the types of rapid assessment tests for which premarket notification must include validated instructions for use and validation data.
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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
Business recordsDrug safety, medical device, and laboratory regulationGovernment information and archivesHealth technology, devices, supplies
To amend the Federal Food, Drug, and Cosmetic Act to enhance medical device communications and ensure device cleanliness.
USA115th CongressHR-872| House
| Updated: 2/10/2017
Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2017 or the DEVICE Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to require medical device manufacturers to notify the Food and Drug Administration (FDA): (1) before making changes to the design or reprocessing instructions of a device, and (2) no more than five days after widely disseminating to health care providers in a foreign country communications regarding changes to the design or reprocessing instructions of a device or regarding a safety concern about a device. A device may not be sold if the manufacturer violates these notification requirements. Rapid assessment tests intended to ensure the proper reprocessing of reusable medical devices are defined as medical devices. The FDA must publish a list of the types of rapid assessment tests for which premarket notification must include validated instructions for use and validation data.