CDRH Reports to Congress
Report to Congress: Device Pilot Projects
Report to Congress: Premarket Approval of Pediatric Uses of Devices
- FY 2022-2023 [725 KB]
- FY 2021 [409 KB]
- FY 2019-2020 [839 KB]
- FY 2018 [775 KB]
- FY 2017 [242 KB]
Report to Congress: Special Topics
- Report to Congress: Postmarket Device Safety-Related Communications (2025) [445 KB]
- Report to Congress: Postmarket Device Safety-Related Communications (2023) [512 KB]
- Report to Congress: Breakthrough Devices Program (2019) [456 KB]
- Report to Congress: Least Burdensome Training Audit (2018) [4.9 MB]
- FY 2016 Report to Congress: Premarket Approval of Pediatric Uses of Devices
- FY 2015 Report to Congress: Premarket Approval of Pediatric Uses of Devices
- FY 2014 Report to Congress: Premarket Approval of Pediatric Uses of Devices
- FY 2013 Report to Congress: Premarket Approval of Pediatric Uses of Devices
- FY 2012 Report to Congress: Premarket Approval of Pediatric Uses of Devices
- FY 2009- 2011 Report to Congress: Premarket Approval of Pediatric Uses of Devices
- FY 2008 Report to Congress: Premarket Approval of Pediatric Uses of Devices
- Quality, Safety, and Effectiveness of Servicing of Medical Devices (FDARA 710) Report
- Report to Congress: FDA's Policy to be Proposed Regarding Premarket Notification Requirements for Modifications to Legally Marketed Devices
- FDA Report to Congress: Improving the Prevention, Diagnosis, and Treatment of Rare and Neglected Diseases
- Medical Device Innovation Initiative White Paper