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5. FDA. Chapter I—Food and Drug Administration, Department of Health and Human Services. Subchapter H—Medical devices. Part 820—Quality system regulation. In: FDA. CFR - Code of Federal Regulations Title 21. Title 21—Food and drugs. Vol. 8. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart_820&showFR_1 Accessed August 2011.