FDA-CDRRHR Releases Updated 2025 Citizen's Charter
The Food and Drug Administration – Center for Device Regulation, Radiation Health, and Research (FDA-CDRRHR) has released its updated Citizen's Charter for 2025, reflecting the agency's continuing efforts to streamline regulatory processes, enhance transparency, and improve client services. This article provides a concise comparison between the 2024 and 2025 editions, highlighting key updates that affect stakeholders in the medical device sectors.
Key Updates in the 2025 Version
| Category – Processing Time | 2024 Citizen's Charter | 2025 Citizen's Charter |
|---|---|---|
| Initial Application – Class A | 25 WD | 23 WD 2H 30MIN |
| Initial Application – Class B | 80 WD (Abridged: 20 WD) |
80 WD 15 MIN (Abridged: 19 WD 7H 55MIN) |
| Initial Application – Class C and D | 110 WD (Abridged: 20 WD) |
109 WD 7H 15MIN (Abridged: 20 WD 15 MIN) |
| Initial Application – IVD | 105 WD | 293 WD 6H 25H |
| Variation/Change Application | 20 WD | 19 WD 5H 45MIN |
| Renewal Application – Devices | 20 WD | 19 WD 7H 15MIN |
| Renewal Application – IVD | 20 WD | 202 WD 6H 25MIN |
WD = Working Days
Improved Efficiency for Medical Device Applications
The 2025 Citizen's Charter introduces both reduced and extended processing timelines across various application types, reflecting refined workflow calibration based on service complexity and laboratory involvement.
Notably, timelines for Class A to D applications have been shortened, ranging from a few hours to two working days faster than in 2024. These reductions suggest improved efficiency within the FDA-CDRRHR's internal review and digital processing systems, supporting faster turnaround for low- to high-risk medical device applications.
Extended Timelines for IVD Applications Due to New Laboratory Testing Requirements
In contrast, IVD (In Vitro Diagnostic) applications, both for initial and renewal submissions, show a significant increase in total processing time. This extension, from 105 WD to 293 WD for initial applications, is primarily attributed to the additional 180 working days allocated for performance testing conducted by the National Reference Laboratory (NRL). This new inclusion ensures that laboratory validation forms an integral part of the regulatory assessment, enhancing the scientific rigor and reliability of IVD evaluations.
Implications for Stakeholders – Driving Regulatory Transparency and Industry Confidence
For stakeholders, this means a clearer distinction between administrative review time and technical performance testing, allowing more accurate project planning and compliance scheduling.
These updates reflect FDA-CDRRHR's ongoing commitment to transparency, data-driven service measurement, and continuous improvement, aligning regulatory performance with both industry advancement and public health protection.
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Reference
FDA-CDRRHR Citizen's Charter 2025