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