February 4, 2026
By Sarah Fitzgerald
The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) recently released their 2025 Annual Report highlighting their achievements over the past year.
Background on US FDA CDRH in 2025
CDRH is responsible for regulating medical devices in the US. They received more than 21,700 submissions of all types in 2025, which is about 1,000 more than in 2024.
The FDA mission, as it pertains to medical devices, can be summarized as:
- Protecting the public health by ensuring the safety and effectiveness – and as of 2023 the security – of medical devices.
- Advancing the public health by helping to speed innovations.
- Fostering the development of medical products to respond to emerging public health threats.
We’ll summarize their annual report in relationship to the CDRH mission and provide some context.
Protecting the public health
FDA protects the public health in two primary manners: pre-market requirements and post-market requirements. CDRH highlighted both manners of protection in their 2025 annual report.
Protecting the public health: Pre-market information and requirements
Pre-market requirements include FDA review of submissions, including those to align with the FDA (like Q-submissions, 513(g) requests, etc.) and submissions to allow a company to start marketing a device (510(k)s, premarket applications [PMAs], etc.). By reviewing these applications before allowing devices to be sold, CDRH helps ensure that the devices have been evaluated and tested in a reasonably consistent manner to support safety, effectiveness, performance, and security of medical devices.
As previously noted, CDRH received about 21,700 submissions of all types in 2025. They did not specify the types of submissions, so Emergo by UL conducted a search to understand approximate numbers. Note that this search was technically for when a device is authorized rather than what submission was made, and denied submissions don’t show up on these searches, so the numbers will not exactly match with submissions received, but provide a high-level picture. In 2025, FDA authorized:
- 3,238 510(k)s
- 9 Emergency Use Authorizations (EUAs) (all 9 related to COVID-19)
- 27 De Novo reclassification requests (de novos)
- 41 Premarket Applications (PMAs) plus 2,210 PMA supplements
- 1 Humanitarian Device Exemption (HDE) plus 114 HDE supplements
Of these, the FDA noted that 124 authorizations in 2025 were for novel medical devices and that they have authorized over 1,300 artificial intelligence (AI) enabled devices to date. Overall, the FDA authorized a total of 5,640 marketing submissions over the course of 2025, slightly higher than the 5,564 authorized in 2024. The balance, about 16,140 submissions, presumably consist primarily of Q-submissions, 513(g) requests, and Investigational Device Exemptions (IDEs) submitted before a marketing authorization submission, plus some marketing submissions that CDRH either declined to review or reviewed but did not authorize.
Protecting the public health: Post-market information and requirements
Overall, post-market requirements related to adverse event reporting, corrections, and recalls were not reported to have significantly changed over 2025.
The FDA stated that their expanded Early Alert Program accelerated communication of potentially high-risk device recalls, enabling increased transparency and enhancing patient safety, and expanded this pilot program to all device types in 2025. The further noted that they issued 125 safety-related communications in 2025.
The FDA notes that they took action on 14 notifications of potential medical device shortages in order to mitigate patient impact.
Advancing the public health
The CDRH annual report focused heavily on how the FDA perceives that they are advancing the public health.
CDRH states that they issued 21 guidance documents, including one that significantly expanded the expectations related to cybersecurity. Guidance documents are critically important for industry to understand FDA’s current thinking and to be able to ensure that they are addressing FDA considerations proactively. Emergo consultants reviewed guidance documents from 2025 for CDRH and found 32 guidance documents that included CDRH released in 2025, several of which also included other branches of the FDA and likely were considered led by those other branches. The topics that had three or more guidance documents released in 2025 were:
- Device Type Specific: 6
- Clinical Testing and Evidence Related: 6
- Submissions Administrative / General Related: 8
All other topics had one or two guidance documents published. Of particular importance were guidance documents related to Predetermined Change Control Plans (PCCPs), cybersecurity expectations, regulatory remote assessments, providing scientific information on unapproved uses of devices, and notifying the FDA of a discontinuance or significant interruption in manufacturing. Additional topics addressed were wide-ranging.
CDRH stated that there are now more than 100 regulatory science tools (RSTs) available. However, note that RSTs have not been qualified as medical device development tools (MDDTs) and CDRH has not evaluated the suitability of these tools within any specific context of use. For comparison, CDRH noted that they qualified one new MDDT and there are only 19 MDDTs that have been qualified for a specific context of use. Therefore, the FDA generally recommends a Q-submission before utilizing RSTs for any premarket submission.
CDRH highlighted their efforts to facilitate innovative devices reaching the market, including granting 149 Breakthrough Device designations and 10 Safer Technology Program (STeP) designations.
Other discussions in the report
CDRH also highlighted various initiatives and information that don’t clearly fall within one of the categories of their mission.
The FDA noted that they are focused on collaboration, including that they participate in 17 collaborative communities, are providing feedback through the Total Product Life Cycle Advisory Program (TAP) Pilot, and are working with the International Medical Device Regulators Forum (IMDRF) to propose manners in which regulatory authorities can leverage regulatory decisions from other regions.
Additionally, the FDA states they are focused on patient-centricity including having 11 ongoing patient-centered research projects, encouraging technologies to bring healthcare into the home through the Home as a Health Care Hub initiative, and introducing the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot program.
The FDA focused on expanding the use of patient-reported outcomes in device authorizations, including that 54% of medical device premarket applications (PMAs) included patient-reported outcomes.
The FDA noted that they are using new digital tools internally, including a generative AI tool called Elsa for routine tasks.
Additional CDRH activities in 2025
Although not discussed in the 2025 annual report summary, there are some additional points that Emergo believes should be mentioned for a fuller picture of CDRH activities in 2025.
CDRH vacated their 2024 rule related to Laboratory Developed Tests (LDTs) which would have required LDTs be subject to standard medical device safety and effectiveness requirements under FDA oversight. Therefore, these tests will remain under enforcement discretion, as they have since 1976.
Following their announcement in 2024 of their intention to reclassify most high risk IVDs from Class III and requiring a PMA to Class II and requiring a 510(k), the FDA reclassified Hepatitis B Virus (HBV) tests (three product codes) is 2025. The 2024 announcement had specifically noted IVDs related to HBV, Human Parvovirus B19, and Mycobacterium tuberculosis were all expected specifically to be reclassified, so additional reclassifications are expected in the future.
Concluding remarks
CDRH conducted various activities in alignment with all three of their overarching missions throughout 2025 and continues to take steps to support safety and effectiveness of devices for their intended use in the U.S.
As we look ahead to 2026, manufacturers need to build out compliance with the Quality Management System Regulation (QMSR) and be aware that the US FDA will perform inspections according to the Compliance Program Manual (CP 7382.850).
Sarah Fitzgerald is regulatory program manager and senior RA/QA consultant at Emergo by UL.
