FDA Classifies Suitable Accessories into Class I as Required by the FDA Reauthorization Act of 2017

2019-07290.pdf



FDA Classifies Suitable Accessories into Class I as Required by the FDA Reauthorization Act of 2017

Today, 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: If the accessory is for use in supporting or sustaining human life, or of substantial importance in preventing impairment to human health; Whether the accessory represents a potential unreasonable risk of illness or injury; and If general controls alone would be sufficient to provide a reasonable assurance of safety and effectiveness of the accessory.    This final classification action will be effective on May 13, 2019.

Read Final Classification Action

Questions? If you have any questions about this proposed list of accessories, please contact the Center for Devices and Radiological Health’s Division of Industry and Consumer Education (DICE) atDICE@fda.hhs.gov, or by phone at 1-800-638-2041, or 301-796-7100.   Food and Drug Administration Center for Devices and Radiological Health