A bill to amend the Federal Food, Drug, and Cosmetic Act to provide for the appropriate, risk-based classification of device accessories based on intended use.
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 regulationGovernment information and archivesHealth technology, devices, supplies
A bill to amend the Federal Food, Drug, and Cosmetic Act to provide for the appropriate, risk-based classification of device accessories based on intended use.
USA115th CongressS-1070| Senate
| Updated: 5/8/2017
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.