• ljboulet

FDA Announces Notice of Intent to Make Temporary Regulatory Flexibilities Permanent

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."

Read more here:

Jan 15 FDA
Download PDF • 276KB

101 views0 comments

Recent Posts

See All