Comparison of Priority vs Standard US Food and Drug Administration Premarket Approval Review for High-Risk Medical Devices

Antzeko izenburuak

• Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements
  nork: Zheng, Sarah Y., et al.
  Argitaratua: (2017)
• Assessment of Clinical Trial Evidence for High-Risk Cardiovascular Devices Approved Under the Food and Drug Administration Priority Review Program
  nork: Jones, L. Camille, et al.
  Argitaratua: (2018)
• Quantification of US Food and Drug Administration Premarket Approval Statements for High-Risk Medical Devices With Pediatric Age Indications
  nork: Lee, Samuel J., et al.
  Argitaratua: (2021)
• Inclusion of Demographic-Specific Information in Studies Supporting US Food & Drug Administration Approval of High-Risk Medical Devices
  nork: Dhruva, Sanket S., et al.
  Argitaratua: (2017)
• Risk of Recall Among Medical Devices Undergoing US Food and Drug Administration 510(k) Clearance and Premarket Approval, 2008-2017
  nork: Dubin, Jonathan R., et al.
  Argitaratua: (2021)