US FDA CDRH 2024 Annual Report Summary

By Sarah Fitzgerald

The United States Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) recently released its 2024 Annual Report (link currently broken, but we will post once available from CDRH) highlighting some of its achievements over the past year. This is a summary of the main topics.

The US FDA CDRH in 2024

The CDRH is responsible for regulating medical devices in the U.S. It has  2,260 dedicated staff members and received over  20,700 submissions of all types in 2024. This represents an increase of about 30 staff members and 1,600 submissions as compared to its 2023 Annual Report.

The FDA's mission, as it pertains to medical devices, can be summarized as:

• Protecting the public health by supporting the safety and effectiveness – and as of 2023 the security – of medical devices.
• Advancing public health by helping to speed innovations.
• Fostering the development of medical products to respond to emerging public health threats.

Here we summarize its annual report in relationship to the CDRH mission and provide some context based on our knowledge and experience.

Protecting public health

The FDA protects public health in two primary manners: pre-market requirements and post-market requirements. CDRH highlighted both manners of protection in their 2024 annual report.

Protecting 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 to help support  the safety, effectiveness, performance and security of medical devices.

As previously noted, the CDRH received about 20,700 submissions of all types in 2024. It did not specify the types of submissions, so we at 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 these numbers will not exactly match up to submissions received, but are sufficient to provide a high-level picture.

In 2024, FDA authorized:

• 3,107 510(k)s
• 48 Emergency Use Authorizations (EUAs) (one related to Middle East Respiratory Syndrome Coronavirus [MERS-CoV], four related to Monkeypox/mpox, and 43 related to COVID-19)
• 47 De Novo reclassification requests (de novos)
• 33 Premarket Applications (PMAs) plus 2,217 PMA supplements
• 4 Humanitarian Device Exemptions (HDEs) plus 108 HDE supplements

Therefore, overall, the FDA authorized a total of 5,564 marketing submissions over the course of 2024, which is slightly lower than the 5,807 authorized in 2023. The balance, about 15,100 submissions, presumably consists 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.

CDRH issued a final rule to require most laboratory-developed tests (LDTs) to be phased out of the general enforcement discretion approach and instead to be regulated in the same manner as standard in vitro diagnostic (IVD) devices, including requiring any applicable marketing authorization applications. They have provided a four-year phase-out, as summarized here:

• May 6, 2025: Requirements for complaint management, adverse event reporting, and corrections and removals.
• May 6, 2026: Requirements for establishment registration and device listing, adequate labeling, and investigational use requirements.
• May 6, 2027: Complete compliance with Quality Management System Requirements.
• November 6, 2027: Premarket submissions must be made for devices requiring PMAs, de novos, and CBER licensing.
• May 6, 2028: Premarket submission must be made for devices requiring 510(k)s.

Additionally, it announced its intention to reclassify most high-risk IVDs from Class III (requiring a PMA) to Class II,(requiring a 510(k)). This means that most current LDTs would require either a de novo reclassification request (de novo) to be granted or a 510(k) to be cleared. This could be challenging for many LDT developers, as they often are not traditional manufacturers, but will help support the safety and effectiveness of these devices to Improve patient care.

CDRH identified certain laboratories that they believe have data integrity issues and has declined submissions that had testing from these laboratories.

As initiated by the FY23 Omnibus and begun in earnest in 2023, CDRH has continued to require more information related to cybersecurity in premarket submissions to help support the security of the device, even when the submission is for a change that does not directly affect cybersecurity. This constitutes more work for both the manufacturer and the FDA. The FDA notes that taking these robust actions helps confirm that medical devices in the U.S. are the most secure in the world.

Protecting 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 compared to 2024. CDRH noted a pilot communication program related to recalls aimed at improving the overall timeliness of communications for high-risk recalls/corrective actions.

The CDRH noted that they actively participated in post-market communications for safety concerns including recalls through various formats. They also issued safety communication warnings related to certain plastic syringes manufactured in China, implementing import alerts and spurring recalls. 

Additionally, the FDA noted that they issued 44 warning letters related to various violations.

Advancing public health

The CDRH annual report s heavily on how the FDA perceives that they are advancing public health in a variety of ways.

First, the CDRH states that it published 38 guidance documents. Guidance documents are critically important for the industry to understand FDA’s current thinking and to be able to confirm that  it is addressing FDA concerns. When Emergo reviewed guidance documents from 2024 for CDRH, we found 50 guidance documents related to CDRH released in 2024, including 24 draft guidance documents and 26 final guidance documents. The topics that had three or more guidance documents released in 2024 were:

• Device type specific: 16
• Clinical testing related: 7
• Handling of emergencies including Emergency Use Authorizations (EUAs): 3
• Accreditation Scheme for Conformity Assessment (ASCA): 3

All other topics had one or two guidance documents published. Of particular importance were guidance documents related to the relatively new concept of Predetermined Change Control Plans (PCCPs), evaluating thermal effects in medical devices, cybersecurity expectations, addressing misinformation and utilizing electronic user manuals. Additional topics addressed were wide-ranging.

The CDRH noted that it has  published three final or draft rules, as summarized below:

• Quality system regulation: This final rule aligns quality system requirements more closely with the international standard ISO 13485:2016. The implementation date is February 2, 2026. Most international manufacturers will need minimal updates, but manufacturers focused solely on the U.S. may need significant quality system updates.
• Laboratory-developed tests (LDTs): Initially issued as a proposed rule early in the year and then as a final rule later, this rule phases out general enforcement discretion currently applied to LDTs and requires standard requirements aligned with IVD requirements for most LDTs, as further described above.

The CDRH stated that there are now more than 150 regulatory science tools (RSTs) available and that they have been leveraged in nearly 1,400 premarket submissions across 536 unique product codes. However, note that such tools 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, there are only 18 MDDTs that have been qualified for a specific 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 156 Breakthrough Device designations, 17 Safer Technology Program (STeP) designations, and granting market authorization to 120 novel devices including 42 devices designated as a breakthrough and 47 de novos.

As we at Emergo previously noted related to the 2023 CDRH Annual Report, the FDA appears to be more rigorously interpreting the meaning of intended use, therefore devices that would previously have been eligible for a 510(k), now must go through the de novo submission process. We note that de novos have higher user fees and generally require significantly more testing (generally including clinical testing) and overall review time, including addressing FDA questions, than a 510(k). We are therefore concerned with this apparent jump in de novos granted in 2023 and the continuing high number in 2024 may be in part due to changing interpretations and may increase the time and resources needed to bring safer and more effective devices to market, which ultimately could translate to higher costs for the devices and therefore for overall health care.

CDRH stated that they have authorized over 1,000 artificial intelligence/machine learning (AI/ML) devices now, including more than 150 in 2024.

In 2023, the CDRH transitioned the Accreditation Scheme for Conformity Assessment (ASCA) pilot to a permanent, voluntary program. In this program, the FDA accredits a laboratory to conduct certain tests, and then the manufacturer only needs to provide summary test reports to the FDA. This is expected to reduce questions and review time for the FDA. In 2024, the CDRH provided additional guidance and conducted a public workshop on the possible expansion of the program.

In 2023, CDRH launched a pilot of the Total Product Life Cycle (TPLC) Advisory Program (TAP) to allow for earlier and more frequent interactions with the industry for innovative devices. In 2024, this program was expanded and, as of the end of 2024, there were 63 Breakthrough Devices enrolled in the program.

Responding to emerging public health threats

The FDA noted that it continues to develop strategies to help prevent and mitigate supply chain disruptions and shortages, including completing the development of a publicly available Critical Medical Device List (CMDL) and maintaining the Medical Device Shortages List. The FDA notes that the CMDL list overlaps with the 506J Device List but is broader in scope. However, Emergo was unable to locate a final CMDL. The 506J Device List, which was authorized in response to COVID-19 in the FY2023 Omnibus authorized in 2022 allows the FDA to require manufacturers of devices important for dealing with an emerging public health threat to notify the FDA of a permanent discontinuance or significant interruption in the manufacture of such devices, and FDA expectations have been provided in a related guidance document. The 506J Device List includes 262 diverse product codes, approximately 4% of medical device product codes. There are thousands of manufacturers for these devices, combined. It is not clear how the FDA will be able to curate this data in a useful fashion given the significant number of such devices and manufacturers, nor the overall impact to industry. It is clear that this institutes additional burden for both industry and the FDA.

Other CDRH initiatives

CDRH also highlighted various initiatives and information that don’t clearly fall within one of the categories of their mission.

CDRH launched Home as a Health Care Hub, a virtual reality-enabled prototype home environment intended to identify potential barriers and critical features of a home to inform how medical devices can better be incorporated in such environments in a holistic manner.

CDRH discussed various collaborations that they have devoted resources to throughout 2024.

Concluding remarks

CDRH conducted various activities in alignment with all three of their overarching missions throughout 2024 and continues to take steps to confirm that devices in the U.S. are safer and more effective for their intended use.