FDA Standards Recognition and USe Guidance

FDA updated its guidance related to standards recognition on 17-Sep-2007. The full document is at the link provided. It describes requirements for the declaration of conformity description and discusses documentation required and limitations of use of consensus standards. This is relevant for use of software standards such as ISO 62304 as well as all other relevant standards.

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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