The past six months at the US Department of Health and Human Services and the US Food and Drug Administration’s Center for Devices and Radiological Health have seen a fluctuating workforce size, a slew of new executive orders, and a new mode of operating. This LawFlash discusses strategies to help device companies navigate this time of change to ensure their device development stays on track and take advantage of any new opportunities.
Earlier this year, we analyzed the significant implications of recently issued executive orders on the oversight of medical devices and digital health products in our LawFlash How New Executive Orders May Affect FDA’s Medical Device Operations. Since then, approximately 3,500 US Food and Drug Administration (FDA) employees were laid off as part of a reduction in force; and while some have recently been reinstated, many others have resigned or retired.
The exact number of employees that have left the Center of Devices and Radiological Health (CDRH) is currently unknown. With the steady stream of departures over the past few months, CDRH has lost significant institutional knowledge. While these recent workforce changes may be disrupting CDRH’s daily functioning in the short term, the personnel changes could create new opportunities in the long term.
As CDRH adjusts to the current environment, CDRH senior leadership, who often are engaged to resolve disputes or consider issues involving novel and complex technologies, may have less bandwidth for meetings internally and externally. Although CDRH leadership has been relatively unchanged since the start of the administration in comparison to other FDA centers (except for the departure of Director of the Office of Product Evaluation and Quality Dr. Ross Segan), the constant changes to the work environment and deregulatory initiatives will likely dominate leadership’s schedules.
Companies need to be aware that when faced with time pressures and challenging or novel issues, less experienced CDRH staff might be less willing to think flexibly or creatively and will be quick to reach for the easiest answer: “No.” And while it is possible that the structural shifts within CDRH may allow new voices and ideas from within the agency to flourish, it also means that companies that approach interactions with CDRH strategically may be more likely to get to the same staff to “yes.”
To capitalize on these opportunities and overcome challenges that may arise, bear the following in mind:
Between the staffing shake up at FDA, the US administration’s emphasis on deregulation, and the executive order requirement that actions be grounded in the “best reading” of the law, companies should not assume that past regulatory approaches will continue to be the most efficient or effective. Device law provides room for flexibility, permitting multiple options for regulatory approach.
Experts who understand where these flexibilities lie and how CDRH operates will be essential to identifying the optimal regulatory approach. Not only can they help sort through viable options, but they can also help advocate for the preferred approach in a manner to which CDRH is most receptive, leading CDRH to reach conclusions that also achieve the company’s business objectives.
When issues or challenges arise, such experts can help companies strategically navigate hurdles and engage in informed, risk-based problem solving. This includes considering all viable options when disagreements arise with CDRH.
With the loss of institutional knowledge and the remaining staff being asked to do more with less, companies may see longer review times. For example, CDRH has only granted marketing authorization for three devices through the de novo pathway in the first quarter of 2025. In comparison, CDRH granted 10 marketing authorizations under the same pathway within the same time frame of 2024.
A less resourced CDRH may also need to reprioritize its workload, taking into consideration the priorities of the administration and its capacity. This could entail focusing its review on areas of public health risk/need as well as activities connected to user fees or that are considered deregulatory. Informal feedback from review divisions and formal meetings not mandated by statute or regulation could become more challenging to obtain on a timely basis or at all.
The pre-submission program, which historically has been helpful in guiding industry through the premarket process, is most vulnerable to any reprioritization efforts because it is not statutorily or regulatorily mandated nor is it associated with a user fee.
In early June 2025, FDA announced the use of a generative artificial intelligence (AI) tool, ELSA, to assist with product evaluations. The application of AI for product reviews warrants specific consideration, which we discussed in a separate As Prescribed blog post, FDA’s AI-Assisted Review: The Next Stage of Regulated Product Evaluation. As of today, whether this tool will assist FDA with its workload and result in more timely feedback remains to be seen.
When device companies are able to interact with CDRH, it will be important for them to approach these interactions strategically to ensure that they are constructive and feedback is timely received. In this regard, companies will need to be prepared and focused. How information is presented and the context provided for the questions asked is critical to receiving meaningful feedback.
In written materials and presentations, companies should aid CDRH’s review by clearly setting forth their positions, justifying preferred approaches, and providing sufficient regulatory and scientific information and precedent tied to the preferred approach. This will give the agency something concrete to react to and provide guidance on.
Articulating a position in a clear and justified manner will also aid CDRH staff with internal discussions with senior leadership and decision-makers. It also can be useful to connect information provided to CDRH to the benefits and risks of the product and outline any pertinent information about the future value of the product, such as meeting an unmet medical need, providing improved or alternative treatment options, or describing the innovative nature of the technology.
Effectively communicating with FDA involves a rigorous and focused approach. Use of internal and external experts prior to interacting with CDRH can also help refine presentations, identify potential pitfalls, and improve overall advocacy to ensure that desired outcomes are achieved. Ultimately, companies that make a concerted effort to prepare and focus their regulatory interactions are more likely to achieve success. As always—but critical in times of constant change—companies should properly document their interactions with and decisions from CDRH to preserve institutional knowledge and facilitate future discussions.
The medical device industry will need to adjust to a less communicative center. Not only did CDRH lose its communications staff, but other policies, such as Executive Order 14192, which requires a “10-to-1” deregulatory policy, coupled with the reductions in staff across the agency, will make it more challenging for CDRH to issue final regulations and industry-wide guidance explaining its thinking on device-specific and programmatic matters at the pace that industry is used to.
Nonetheless, CDRH has begun issuing new documents. As discussed in an As Prescribed blog post, Navigating FDA’s Evolving Approach to Guidance Publication for Medical Products, draft guidance and proposed orders are not subject to Executive Order 14192, which opens up an avenue for CDRH to communicate its current thinking without implicating the need to remove existing regulations or guidance documents. These documents will help provide a window into CDRH’s current thinking, and we will continue to monitor to determine if any trends emerge.
Despite the fact that CDRH has begun issuing documents, there has not been an update to the CDRHNew or Press Announcement webpages since January. The loss of these useful webpages puts the onus for monitoring FDA activity on others.
Monitoring decisions and warning letters regarding third-party products and assessing their scientific, legal, and regulatory applicability to the sponsor’s own development programs will become increasingly critical as a lower-staffed CDRH may not be able to provide answers to companies through individual interactions. Instead, much of CDRH policies will likely be implemented through individual adjudications and actions on specific products, which may or may not be publicly available.
Interpreting this type of precedent requires expertise with identifying and navigating CDRH trends and changes. Companies should ensure they have the right team with the appropriate knowledge base to help engage in collaborative discussions and informed, risk-based decisions.
The January 23, 2025 executive order related to AI establishes an overarching directive to maintain US leadership in AI. To that end, the US administration is focused on removing barriers to AI innovation. CDRH currently has on staff individuals with expertise in AI. They were rehired only two weeks after being laid off as part of the removal of probationary employees. Their swift rehiring and retention demonstrate the US administration’s commitment to ensuring CDRH has the expertise to help advance innovation in this space.
As discussed above, CDRH may be limited in its ability to issue formal final guidance with respect to AI-enabled devices, which means FDA may be slow to finalize its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations, which was issued in January 2025. This silence does not mean CDRH is any less focused on the use of AI in devices than it was previously. CDRH silence only further increases the importance of monitoring its activities to discern relevant precedent for AI-enabled devices. This is an area ripe for creative thinking, where expertise can help optimize the regulatory approach and maximize interactions with CDRH.
Remaining up to date on CDRH during this time of change be challenging, but it also opens the possibilities of new opportunities for companies that make a concerted effort to prepare with regards to all submissions and interactions with the agency.
Morgan Lewis is well-versed in providing strategic counseling for life sciences, medical technology, and digital health companies. Morgan Lewis has professionals who are former FDA employees and with experience in guiding and assisting companies with assessing, anticipating, and navigating regulatory and legal changes specific to the regulation of medical devices, AI, and other digital health technologies at both the federal and state levels.
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