As published by the Department of Health and Human Services on January 15, 2021: Making Permanent Regulatory Flexibilities Provided During the COVID–19 Public Health Emergency by Exempting Certain Medical Devices From Premarket Notification Requirements; Request for Information, Research, Analysis, and Public Comment on Opportunities for Further Science and Evidence-Based Reform of Section 510(k) Program
“SUMMARY: To provide Americans with expanded access to certain medical devices to respond to the COVID–19 Public Health Emergency, FDA issued guidance documents providing numerous regulatory flexibilities, including a temporary waiver of premarket notification requirements under section 510(k) of the Food, Drug, and Cosmetic Act. For seven class I devices for which 510(k) premarket review as temporarily waived during the PHE, the Department of Health and Human Services is permanently exempting those seven (7) class I devices from the 510(k) requirement and is also proposing to exempt an additional 83 class II devices and 1 unclassified device class from the 510(k) requirement, for which premarket review had also been waived during the PHE.”The body content of your post goes here. To edit this text, click on it and delete this default text and start typing your own or paste your own from a different source.
