Difference between revisions of "CFR 21-820 - Quality System Regulations"
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Revision as of 07:19, 25 August 2020
These regulations implement FDA's responsibilities and authority over medical device manufacturers management, design, development, verficiation, manufacture, validation, distributoin, installation, support, quality assurance and records for each new or listed device.
This regulation is the major regulatory thrust of day-to-day FDA oversight of device manufacturers and the focus of this book. Most of the remaining chapers are specific to the Quality System Regulation. These regulations are also the agency's attempt to harmonize medical device regulation with international quality standards, specifically ISO 9000.
The Quality System Regulations are philosophically simple:
- Comply with the regulations
- Say what you do
- Do what you say
- Document that you have done what you say
The CFR regulations described with respect to Quality System Regulations are:
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