Day

August 20, 2020
An important lesson from a Warning Letter citing FB Claims: In this Warning Letter to SilveryGuy, dated August 14, 2020, FDA – CDER informed the recipient that they had evaluated the company’s website and Facebook (FB) page. This demonstrates that even social media claims can establish the intended use of a product. Be careful what your...
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My Software Is a Medical Device … if that’s you, check out this upcoming webinar.  Our very own John Murray will participate in a webinar on August 25, 2020, and join a roundtable discussion with Bakul Patel, Director, Division of Digital Health at FDA.  Shawnnah Monterrey, CEO @BeanStock Ventures will moderate the discussion. You can...
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What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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