According to the FDA’s public database, since the start of this year, the agency has issued only two de novo medical device clearances.
That includes the Jan. 17 green light of Myocene’s neuromuscular evaluation system, with its sensor patches designed to objectively measure quad muscle fatigue in athletes during training, and the CORIS device from Nanosonics, OK’d just this week for cleaning out the narrow internal channels of reusable endoscopes.
By comparison, during the first quarter of 2024, the FDA had cleared 12 de novo devices—about the agency’s quarterly average spanning more than the past two years—including a robotic surgery system, smartwatch-based sleep apnea detection, and artificial intelligence algorithms for diagnosing cervical cancer or predicting a patient’s chances of developing Alzheimer’s disease and dementia.
The decline follows an initial round of the Trump administration’s DOGE-led layoffs at the agency’s devices center, which included staff tasked with reviewing products, and comes amid a new plan to reorganize the Department of Health and Human Services that may see as many as 3,500 full-time positions eliminated at the FDA.
De novo devices are trailblazing medical products considered to carry low or moderate risks. Once determined to be safe and effective, their clearances open up new regulatory pathways for other developers of future systems under the same category—allowing innovators to then pursue the less-stringent 510(k) clearance process, by demonstrating substantial equivalence to the original device while adding new iterations and improvements.
Hardware that poses higher risks to patients undergoes a more comprehensive review for premarket approval. In that category, the FDA has granted four original green lights so far this year, compared to seven by this point in 2024.
Novel high-risk devices also include those granted humanitarian exemptions—for use in rare diseases, and in the treatment of no more than 8,000 U.S. patients per year—and they are far less frequent. In all of last year, the FDA handed out only four new exemptions, including one in February 2024 that covered a pediatric cartridge for continuous renal replacement therapy developed by SeaStar Medical. No exemptions have been issued so far in 2025.
According to the FDA’s most recent quarterly report of product review performance, the agency had 46 pending de novo product applications on its to-do list as of December 31, 2024—including the now-cleared devices from Myocene and Nanosonics, which were first accepted for review in July 2023 and May 2024, respectively.
Under premarket approvals, the agency had 60 applications for new devices listed as pending at the end of last year, plus 151 supplemental applications from developers seeking permission to make updates to previously approved devices.
An FDA spokesperson told Fierce Medtech that the agency does not typically comment on the early steps in the review process—such as whether product submissions have been received—and would not say how many new applications were accepted in the first three months of this calendar year.
While the public database of de novo clearances is scheduled to be updated weekly, the agency’s next full quarterly accounting of review performance is expected to be published in May.
“There is a multitude of factors that can contribute to an increase or decrease in the number of submissions the FDA receives, reviews and makes a determination on,” the FDA spokesperson told Fierce Medtech.
“Novel device submissions made to the FDA through De Novo requests represent a wide range of devices, such as genetic tests for cancer diagnosis, peripheral interventions, atrial fibrillation, spinal implants, wearable technologies that use artificial intelligence/machine learning, and other technologies for at-home use,” the spokesperson added. “Additionally, some possible factors that may influence the number of submissions include technological innovation, unmet health care needs, and investment in research and development.”
Following the new Trump administration’s push to eliminate positions across the federal government, the FDA’s Center for Devices and Radiological Health was the subject of dozens of layoffs—including many probationary employees in their first year or two of service who were hired specifically under legislation that directed the agency to bolster its product review staff.
In addition, some of the affected workers had been tasked with evaluating cutting-edge tech, including AI, because they were recently brought on to try to keep pace with new advancements in the field.
The FDA has been working to reverse the layoffs and rehire lost staff since late February—after some, but not all, employees started receiving phone calls a week later saying they were being reinstated. The agency did not respond to questions regarding the state of staffing at CDRH, and would not provide a current headcount.
On March 27, HHS announced a transformation plan that would result in about 10,000 full-time employees being fired from the department—or about 10% of its staff—in addition to closing half of its regional offices and consolidating its 28 administrative divisions down to 15. After factoring in early retirement and the “fork in the road” offering from earlier this year, the agency’s total headcount would decrease by 20,000 members
In its announcement, HHS said the new cuts at the FDA would not affect device or drug reviewers. The Centers for Disease Control and Prevention, meanwhile, would lose about 2,400 employees, while taking in about 1,000 through the takeover of HHS’ Administration for Strategic Preparedness and Response.
The National Institutes of Health are slated to lose about 1,200, through the centralization of procurement, human resources and communications staff across its institutes and centers.
“We agree with the Secretary’s goal to ensure that HHS and its subagencies are more efficient and accountable,” Scott Whitaker, CEO of the medtech trade association AdvaMed said in a statement. “My understanding is that FDA experts whose entire mission is to improve and not stand in the way of patient access to innovative medtech will not be affected. This is good news.”
“Looking forward, our view is that any reduction in force should be accompanied by policy and regulatory improvements that encourage innovation in medtech,” Whitaker added.
Under the current generation of five-year-long legislation that authorizes the FDA to collect user fees from the medtech industry, known as MDUFA V, the agency agreed to certain performance goals when it comes to reviewing de novo devices.
That includes a base target for returning decisions on de novo requests, with a grant, decline or withdraw stamp within 150 days, for at least 70% of the total submissions received. If a final decision cannot be made within 180 days, the FDA is obligated to discuss with the applicant all outstanding issues preventing the agency from reaching a decision.
According to a report from Reuters, some medical device developers have seen their mid-review and pre-submission meetings with CDRH staff be canceled, or moved to written responses only, following the layoffs earlier this year.
In all of 2024, the FDA issued greenlights for 84 novel devices—including 47 de novo clearances, 33 premarket approvals and four humanitarian exemptions.
Editor's note: On March 28, after publication, the FDA publicized its third de novo clearance of the quarter, with its green light for Visby Medical's at-home STI test.