FDA CDRH QSr Design Control Guidance-obsolete

FDA CDRH’s “Design Control Guidance For Medical Device Manufacturers ” issued May 11, 1997. This guidance provides explanations related to the design control requirements in the Quality System Regulation 21 CFR 820 Section 30 and ISO 9001 clause 4.4. This guidance has many references to software. It is important to recognize that design control and validation of software is done within the context of design control and design validation for the medical device overall.

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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