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August 22, 2020
SoftwareCPR August 2020 Newsletter has been published.  FDA news, regulatory updates, new SoftwareCPR content, software recalls, and software warning letters.
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Why are clinical studies necessary? Medical device clinical studies provide evidence for a PMA submission. Under 21 CFR 860.7, the FDA relies only on “valid scientific evidence” to determine whether there is reasonable assurance that a device is safe and effective. Valid scientific evidence can originate from a variety of sources, including well-controlled studies. Even...
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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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