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21 cfr 820.70 fda qsr 21 cfr part 820 21 cfr 820 preamble 21 cfr 820 part 11 21 cfr 820.181 21 cfr 820.170 qsr part 820 fda 21 cfr 820 cfr 820 medical devices fda qsr 21 cfr 820 cfr title 21 part 820 quality system regulation 21 cfr 820