US FDA published Finalized List of Accessories Suitable for Class I


On 12 Apr 2019, the US FDA published the "Finalized List of Accessories Suitable for Class I" medical devices document, as required by the FDA Reauthorization Act of 2017 (FDARA).

The US FDA has determined that general controls alone are sufficient to provide reasonable assurance of safety and effectiveness for these accessories. This determination was made based on the risks of the accessories when used as intended with other devices such as the parent or system.

This final classification action is effective May 13, 2019.

Source: https://www.federalregister.gov/documents/2019/04/12/2019-07290/medical-devices-classification-of-accessories-distinct-from-other-devices-finalized-list-of

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