FDA Issues Notification Requesting Public Comment on List of Proposed Class I Accessories

FDA Issues Notification Requesting Public Comment on List of Proposed Class I Accessories

Today, the U.S. Food and Drug Administration (FDA) issued a notification, “Medical Devices; Distinct Classification of Accessories; Proposed List of Accessories Suitable for Class I; Request for Comments .” This notification fulfills a requirement that originated with the FDA Reauthorization Act of 2017 (FDARA), by identifying and seeking public comment on a proposed list of accessories that the FDA believes are suitable for distinct classification in class I. 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 proposal 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. The proposal also includes a policy clarification about certain accessories used in orthopedic surgery. We welcome your comments both on the proposed list and to help identify additional product areas for which general controls will provide a reasonable assurance of safety and effectiveness of accessories, and that the FDA may designate as class I. The comment period closes in 60 days.   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