Inclusion of Demographic-Specific Information in Studies Supporting US Food & Drug Administration Approval of High-Risk Medical Devices

Eitemau Tebyg

• Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements
  gan: Zheng, Sarah Y., et al.
  Cyhoeddwyd: (2017)
• Assessment of Clinical Trial Evidence for High-Risk Cardiovascular Devices Approved Under the Food and Drug Administration Priority Review Program
  gan: Jones, L. Camille, et al.
  Cyhoeddwyd: (2018)
• Reporting of Death in US Food and Drug Administration Medical Device Adverse Event Reports in Categories Other Than Death
  gan: Lalani, Christina, et al.
  Cyhoeddwyd: (2021)
• Comparison of Priority vs Standard US Food and Drug Administration Premarket Approval Review for High-Risk Medical Devices
  gan: Ong, Caroline, et al.
  Cyhoeddwyd: (2020)
• Clinical Evidence Supporting US Food and Drug Administration Clearance of Novel Therapeutic Devices via the De Novo Pathway Between 2011 and 2019
  gan: Johnston, James L., et al.
  Cyhoeddwyd: (2020)