The U.S. Food and Drug Administration (FDA) issued the final classification action “Medical Devices; Classification of Accessories Distinct from Other Devices; Finalized List of Accessories Suitable for Class I.” This final classification action fulfills a requirement that originated with the FDA Reauthorization Act of 2017 (FDARA), by publishing a final action classifying suitable accessories into class I within 180 days after the end of the comment period on the proposed list of accessories the FDA issued on August 17, 2018. The classification is based on the risks of the accessory when used as intended and the level of regulatory controls necessary to provide a reasonable assurance of safety and effectiveness.
Key factors the FDA considered for this final classification action include:
This final classification action will be effective on May 13, 2019.
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