FDA DSMA Quality System Manual

FDA CDRH’s division of small Manufacturers Assistance “Medical Device Quality Systems manual: A small entity Compliance Guide”. this manual was issued in December of 1996 shortly after release of the final version of the Quality System Regulation and is at the link provided. It was intended to help explain the Quality System Regulation and how to comply with its requirements. Note that FDA’s old 1990 draft guidance “Application of the Medicall Device GMPS to Computerized Devices and Manufacturing Processes” is included in the appendices but was written long before the Quality System Regulation. While informative in some ways it should not be used literally or as current.

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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