SoftwareCPR.com September 2000 Newsletter

This SoftwareCPR.com newsletter lists items added to the web site since the June newsletter and as of September26, 2000. It serves as an easy reference to find new or updated items that may be of interest to you and provides a full index of SoftwareCPR educational items.

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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