By Sean Fenske, Editor-in-Chief

Following the results of the 2024 presidential election, a new administration took its place in the White House in January 2025. With it came promises of significant changes to many government agencies, including HHS and FDA. Now with many of those changes being implemented, expectations and speculation of how it will impact healthcare is taking place.

For medical device manufacturers, the cuts could lead to a variety of outcomes. No one knows for certain what will occur in the coming months or years, but early indications point to a very different regulatory landscape from what many are accustomed to. Review times, communication with the agency, and regulatory oversight are all in question going forward.

Fortunately, some who interact more regularly than others within the industry are willing to share their experience and expertise to provide more qualified predictions for how these changes could impact medtech. In the following Q&A, four representatives from Nelson Labs provided such insights—Chrystel Lloyd, M.S., Sr. Manager Lab Operations and Strategic Development; Logan Luke, Expert Technical Consultant; Thor Rollins, VP Medical Device Segment; and Martell Winters, Director of Science.

Sean Fenske: Can you please provide an overview of the variety of changes taking place at the FDA recently that could impact the medical device manufacturing industry?

Chrystel Lloyd: FDA changes taking place could impact the medical device manufacturing industry in multiple ways. Changes in agency staffing and regulatory expectations are considered the most crucial. Reductions in agency staffing will ultimately lead to delays in submissions, inspections, and industry participation. Manufacturers may have to wait longer to receive submission feedback and/or final approvals which is even more critical for smaller companies and startups.

Along the same lines, changes in staffing lead to unclear regulatory expectations. Longtime agency staff have created clear expectations for submissions and streamlined processes from their experience. When those individuals exit the agency, it can create confusion and delays due to inexperience, lack of device understanding, and differing expectations. Long term, these delays can affect the supply chain or healthcare facilities and the economic success of the device manufacturer.

Thor Rollins: The most impactful changes from the agency are certainly the reduction of staff, but also the mandate to return to office. Even though most (if not all) of the staff were rehired, many have been looking for other opportunities outside the agency. Those remaining are being forced to return to the office but do not have sufficient resources at the office to do their job.

We also saw a mandate for no outside interaction; this stopped all involvement with standards and even communication with industry. Even though this has been loosened, they are still not attending events in person. I just attended the Society of Toxicology annual meeting, where there was no in-person representation from EPA or FDA.

Martell Winters: Two weeks ago, we were able to have an informal discussion with several members of CDRH regarding a project we are working on. They were very helpful and open to asking questions and sharing thoughts about our project. I’m glad they were given the approval to start interacting with industry again.

Also, in March, I participated in the AAMI Sterilization Standards meetings and even though the FDA representatives were not there in person, they joined the meetings remotely and were active in the discussions. I do anticipate they will be able to return to full interaction regarding industry participation and I look forward to that day. It has been many years now since FDA has been extremely involved in our national and international standards regarding healthcare products and their interaction has been tremendously beneficial. In the committee where I am most involved, we have seen FDA be open to discussion and to exchanging ideas as we work through the details of the standard.

Fenske: With the new administration, there have been leadership changes at the agency. What do you expect this to bring that could impact medtech?

Lloyd: The medtech industry spans across multiple areas of expertise including the manufacturers, the regulatory agencies, and the service providers (e.g., test labs and sterilization facilities). The longtime leaders within the agency have built relationships that span across the entire industry and that has ultimately led to innovation, transparency, and collaboration. It is reasonable to assume that leadership changes now may have an impact on the current relationships and collaborative efforts that took years to put into place.

Rollins: In addition, recent executive orders may delay pending regulations and create uncertainty regarding FDA guidance related to artificial intelligence and other innovations. These changes could impact the approval processes for medical devices.

Fenske: How will the staff cuts impact medical device manufacturers? Will this create delays in review times?

Lloyd: Staff cuts within the FDA are certainly expected to create delays, and we have begun to see this already. FDA cuts have led to manufacturers experiencing longer timelines for both pre-sub and final submission reviews, FDA feedback on test plans, and additional time spent addressing questions due to fluctuations of expertise within the agency. Delays in product approvals create multiple challenges for device manufacturers. Manufacturers may need to adjust time to market plans, when they expect to see revenue impacts for products in approval stages, new product development plans, and which markets to target first, just to name a few.

Logan Luke: I agree. Delays in review times are certainly an outcome that could come as a result of staff cuts. Along with review times, another area I feel will be impacted is the agency’s ability to perform pre-submission meetings. These meetings have been valuable for manufacturers to settle on validation strategies to ensure alignment with the FDA prior to submission and are especially beneficial for de novo devices, which may not be able to follow prior established paths to validation. If these meetings are unable to be held, manufacturers may need to assume more risk by choosing validation strategies without prior approval from the FDA.

Rollins: As my colleagues mentioned, recent staff reductions at the FDA have raised concerns about potential delays. Significant staff departures may negatively impact medical product reviews, with certain product types experiencing greater delays depending on the areas affected by the cuts. In response to industry pushback, the FDA has begun reinstating some staff members, particularly those involved in medical device oversight, to mitigate potential disruptions.

Fenske: What about the reviewers who were let go who were originally brought in for newer innovations like AI? Is the agency able to review all new medical devices that leverage new technologies?

Rollins: The FDA has taken steps to address the review of AI-powered medical devices. The agency has finalized recommendations to streamline the approval process for medical devices utilizing artificial intelligence, allowing manufacturers to update AI-enabled devices without resubmitting extensive documentation. Despite rehiring efforts, concerns remain about the FDA’s capacity to adequately review innovative medical devices, including those leveraging new technologies like AI, due to prior staff reductions.

Winters: These questions are good, but unfortunately any answers at this point are likely speculation as details are still evolving. As Thor mentioned, most of the reviewers who were let go were allowed to come back, but I am not aware of the expertise of those who chose not to return.

Fenske: As the agency aligns more closely with ISO standards, how is this change impacting device manufacturers?

Rollins: Actually, we might see less alignment in some standards. The new ISO 10993-1 standard received a no vote on each ballot by the U.S., indicating that there are potential gaps between the current direction and the agency’s thoughts. Since the reset of the countries voted yes, the standard has moved forward but we might see some dissenting opinions from the U.S.

Winters: I see agency alignment with ISO standards as being very positive. The agency has chosen to align with all of the sterilization-related standards that we follow. This helps manufacturers that are selling to a global market have fewer standards to address. In the sterilization standards, we have seen good participation from FDA, and we have also seen them quickly add new ISO standards to their recognized consensus standards list, which further assists U.S. manufacturers in selling to a global market. Since FDA has been involved with the ISO standards development process, it makes it easier for them to approve new standards or new versions of standards.

Fenske: Are there changes being discussed moving forward or changes you’re anticipating? What additional changes might we see soon that will impact medtech?

Lloyd: As my colleagues have mentioned previously, one of the biggest changes we’ve seen recently is the agency’s ability to participate in medtech conferences and public discussions. Historically, the FDA has been active in industry conversations that span across manufacturing, testing, and research, but attendance and participation in 2025 have decreased dramatically. This is frustrating for the industry because these changes take away from the collaborative environment that keeps innovation and thought leadership going strong. A change that has been in discussion for the future is a focus on improved approval pathways. This could create a quicker, more streamlined approval process for medical device manufacturers, which ultimately leads to quicker time to market for products.

Rollins: Also, I believe we will see a reduction in policies and a push to automate the submission process more.

Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell orthopedic device manufacturers?

Lloyd: Manufacturers and the FDA should continue participating in conferences and open forum opportunities to help drive the industry in the right direction with regulatory expectations and innovation.

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