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fda cfr 820fda 21 cfr part 820fda qsr 21 cfr 820fda medical device 21 cfr 82021 cfr 820.70fda qsr 21 cfr part 820fda 82021 cfr 820 risk management21 cfr 820 preamble21 cfr 820 part 11fda part 82021 cfr 820.181