To amend the Federal Food, Drug, and Cosmetic Act to provide for the appropriate, risk-based classification of device accessories based on their intended uses.
Health Subcommittee, Energy and Commerce Committee
Introduced
In Committee
On Floor
Passed Chamber
Enacted
Risk-Based Classification of Accessories Act of 2017 This bill revises how accessories to medical devices are classified. Specifically, the Food and Drug Administration must classify accessories based on the risks when used as intended , notwithstanding the classification of any other device with which such accessory is intended to be used.
Drug safety, medical device, and laboratory regulationHealth technology, devices, supplies
To amend the Federal Food, Drug, and Cosmetic Act to provide for the appropriate, risk-based classification of device accessories based on their intended uses.
USA115th CongressHR-2144| House
| Updated: 4/28/2017
Risk-Based Classification of Accessories Act of 2017 This bill revises how accessories to medical devices are classified. Specifically, the Food and Drug Administration must classify accessories based on the risks when used as intended , notwithstanding the classification of any other device with which such accessory is intended to be used.