Guidance: FDA Won’t Ask For Notice On Some Device Mods Tied To COVID-19
Sponsors of PMA or HDE-authorized devices can make some modifications in response to COVID-19 without first alerting the US FDA under a recent guidance document.
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The policy allows device developers to change some device materials or manufacturing practices without first alerting the agency, as long as the alterations are a result of manufacturing or supply chain issues.
The government collected $2.68bn from settled False Claims Act cases last year, the US Department of Justice said. Another 12 device-related cases were announced in February alone.
News We’re Watching: Smart Watch Blood Glucose Warning, $100M For Women’s Health, Zimmer Surgical Robot Clearance
This week, the FDA reminded consumers that smart watches and rings are not blood glucose monitors; First Lady Jill Biden announced a $100M women’s health initiative; and the Zimmer ROSA Shoulder System got FDA clearance.