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Annual Report to Congress: Premarket Approval of Pediatric Uses of Devices, FY 2017, 2019. https:\/\/www.fda.gov\/media\/128659\/download (accessed September 1, 2019)."},{"key":"8","unstructured":"8. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluation, Center for Biologics Evaluation Research. Premarket assessment of pediatric medical devices; Guidance for Industry and Food and Drug Administration Staff, March 24, 2014. https:\/\/www.fda.gov\/media\/73510\/download (accessed September 1, 2019)."},{"key":"9","unstructured":"9. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research. Leveraging existing clinical data for extrapolation to pediatric uses of medical devices; Guidance for Industry and Food and Drug Administration Staff, June 21, 2016, https:\/\/www.fda.gov\/media\/91889\/download (accessed September 1, 2019)."},{"key":"10","unstructured":"10. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Center for Biological Evaluation and Research. Providing information about pediatric uses of medical devices; Guidance for Industry and Food and Drug Administration Staff, May 1, 2014. https:\/\/www.fda.gov\/media\/85233\/download (accessed September 1, 2019)."},{"key":"11","unstructured":"11. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research. 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