Medical Devices; Classification of Accessories Distinct From Other Devices; Finalized List of Accessories Suitable for Class I
Information
Type
Rule
Regulated products
Medical Devices
Published
April 12, 2019
Last updated
April 12, 2019
Description
Document number 2019-07290. The Food and Drug Administration (FDA, we, or Agency) is classifying suitable accessories into class I as required by the FDA Reauthorization Act of 2017 (FDARA). The Agency has determined that general controls alone are sufficient to provide reasonable assurance of safety and effectiveness for these accessories. We made this determination based on the risks of the accessories when used as intended with other devices such as the parent or system.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)