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Tuesday, 02/12/2019 9:39:04 AM

Tuesday, February 12, 2019 9:39:04 AM

Post# of 330183
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM283707.pdf




Evaluation of Sex-Specific Data in Medical Device Clinical Studies - U S Food and Drug Administration Home Page


Trust this helps.