Navigating FDA Changes in 2025: Key Insights for MedTech Companies

MedTech Impact Partners has been closely monitoring the evolving FDA landscape through conversations with former and current FDA personnel, investors, and Medtech companies. These insights, combined with those shared in a recent webinar hosted by MedTech Color featuring Steve Silverman and Kwame Ulmer, highlight the significant changes at the FDA under the current administration and their implications for stakeholders. The webinar session, summarized in the accompanying presentation, provided valuable insights into navigating the evolving regulatory landscape, crucial for ensuring premarket success, regulatory compliance, and product quality.

Key Shifts and Strategic Assumptions

The webinar highlighted several key shifts impacting regulatory strategy:

• FDA Review Time: FDA review times are likely to be slower due to staff reductions.

• Regulations & Guidance: There will be a reduced number of regulations and guidance compared to prior years.

• Size: The FDA may shrink instead of the planned increase in staff.

• Funding: FDA funding is expected to decrease.

• Policy (Taxes and Tariffs): There are increased incentives for US manufacturing.

Impact and Evidence

The discussion, informed by our network and detailed further in the presentation, provided evidence of these shifts:

• Staff cuts and departures are slowing review efficiency.

• Layoffs jeopardize user fee programs, impacting FDA's capacity to meet submission targets and delaying renewal of user fee programs.

• The 1-in-10-out policy puts pressure on the FDA to reduce regulations.

• Deregulation of AI creates regulatory uncertainty, potentially delaying AI and digital health reviews.

• FDA layoffs lead to resource constraints, which could de-prioritize lower-risk or smaller-market devices.

• Proposed funding cuts slow Medtech innovation and research and create regulatory uncertainty, impacting industry planning and investment.

• Tariffs are raising production costs for Medtech firms, prompting reassessments of global supply chains.

Mitigation Strategies

Several mitigation strategies consistent with our understanding from industry conversations were identified:

• FDA Review Time: Monitor FDA timelines, escalate thoughtfully, use informal check-ins, and add buffer to timelines.

• Regulations & Guidance: Engage early with the FDA, use precedent, and engage in industry coalitions.

• Size: Clarify roles within the FDA, anticipate delays, and leverage third-party consultancies.

• Funding: Prioritize programs with clear ROI and diversify funding sources.

• Policy (Taxes & Tariffs): Utilize federal programs for domestic manufacturing, diversify supply sources, and engage with industry associations to influence policy.

Conclusion

The insights from the MedTech Color webinar and validated by MedTech Impact Partners' conversations with key stakeholders, provide a roadmap for medtech companies to navigate the changing FDA landscape. By understanding the shifts, anticipating the impacts, and implementing proactive mitigation strategies, companies can enhance their chances of premarket success, maintain regulatory compliance, and ensure product quality.

Download the full slide deck here to get all the details.

Need more specific insights on how MedTech Impact Partners can work with your company to navigate these changes, schedule a call below.

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