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us fda cfrus fda 21 cfr part 11us fda 21 cfr 820fda 21 cfr part 11 regulationsus 21 cfrus fda 21 cfr 176.170us fda reg 21 cfr 801.410us 21 cfr part 11fda 21 cfr part 11 compliancefda guidance 21 cfr part 11fda cfr 21 part 211fda clearance