CDRH Reports to Congress
Report to Congress: Device Pilot Projects
- FY 2022 [PDF - 576 KB]
- FY 2021 [PDF - 425 KB]
- FY 2020 [PDF - 408 KB]
- FY 2019 [PDF - 439 KB]
- FY 2017 [PDF - 699 KB]
Report to Congress: Premarket Approval of Pediatric Uses of Devices
- FY 2024 [PDF - 502 KB]
- FY 2022-2023 [PDF - 725 KB]
- FY 2021 [PDF - 409 KB]
- FY 2019-2020 [PDF - 839 KB]
- FY 2018 [PDF - 775 KB]
- FY 2017 [PDF - 242 KB]
Report to Congress: Special Topics
- Report to Congress: Postmarket Device Safety-Related Communications (2025) [PDF - 445 KB]
- Report to Congress: Postmarket Device Safety-Related Communications (2023) [PDF - 512 KB]
- Report to Congress: Breakthrough Devices Program (2019) [PDF - 456 KB]
- Report to Congress: Least Burdensome Training Audit (2018) [PDF - 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