Regulatory policies in the MedTech and pharmaceutical industries often shift with new administrations. With the current administration proposing sweeping changes, including deregulation, updates to FDA structure and processes, and tariff implementation this blog explores key regulatory changes, their implications, and how businesses can adapt.

---

Watch our experts discuss these changes here.

---

The Push for Deregulation

One of the administration’s primary goals is reducing regulatory burdens on businesses. Previous efforts included requiring the removal of two existing regulations for every new one introduced, and the administration will implement a policy mandating the elimination of ten regulations for every new one enacted. While deregulation could simplify compliance, it may also create significant uncertainties, particularly regarding safety standards and quality assurance. MedTech and pharmaceutical companies must actively track regulatory developments, assess potential risks, and implement strategic measures to ensure ongoing compliance to position themselves for long-term success in an evolving regulatory landscape.

 

FDA Workforce Reductions & Product Approval Timelines

FDA review timelines for drugs fall under the Prescription Drug User Fee Act (PDUFA) and the Generic Drug User Fee Amendments (GDUFA) which regulate review periods for New Drug Applications (NDA) and Abbreviated New Drug Applications (ANDA) are set through 2027.  Similarly, medical device approval timelines fall under the Medical Device User Fee Amendments (MDUFA), which regulate review periods for premarket approvals (PMA) and 510(k) clearances are also set through 2027. While these timelines are unlikely to change, workforce reductions at the FDA may lead to delays, across both drug and medical device reviews. The administration’s focus on automation and AI-driven processes may help counterbalance delays, but adoption of these technologies remains in its early stages. Companies can prepare for possible slowdowns by ensuring their submissions are complete, well-documented, and structured for easy review to avoid costly submission delays.

 

Changes in FDA Inspections and Compliance Expectations

Budget constraints and workforce cuts may lead to longer wait times for FDA re-inspections. In response, the agency is increasing its reliance on remote audits and digital compliance measures.  As the FDA is expected to place greater emphasis on data integrity, AI-assisted compliance monitoring, and risk-based assessments to prioritize critical inspections, companies can strengthen their electronic record-keeping and cybersecurity frameworks to prepare for successful remote, as well as onsite, inspections.

 

The Impact of Tariffs and Trade Policies on Supply Chains

The administration has signaled tariff increases on imported raw materials and medical components, which could significantly impact MedTech and pharma supply chains. Many companies source materials from countries where production costs are lower, but new tariffs may force them to reconsider domestic sourcing or alternative suppliers. Companies can qualify alternative suppliers and appropriately assess the impact of any resulting device or drug product changes with additional testing, documentation, and submission to regulatory bodies, where appropriate.

 

Challenges for Industry Collaboration

A recent policy change has limited the FDA’s participation in industry conferences, working groups, and regulatory collaboration efforts. This has raised concerns about delays in regulatory standardization, test method approvals, and knowledge-sharing initiatives. Companies can take proactive steps to engage with industry organizations, participate in independent regulatory forums, and collaborate with peers to fill the information gap left by the FDA’s reduced engagement. Partnering with regulatory consultants and leveraging external expertise can also ensure continued compliance and strategic industry positioning.

 

Key Takeaways: How Companies Can Prepare

• Enhance Regulatory Compliance: Strengthen quality management systems (QMS) and prioritize data integrity to meet evolving regulatory expectations.
• Prepare for Remote Inspections: Adopt robust digital record-keeping practices and cybersecurity measures to accommodate the FDA’s shift toward virtual audits.
• Diversify Supply Chains: Evaluate sourcing strategies to mitigate risks associated with potential tariff increases and supply chain disruptions.
• Stay Engaged with Industry Networks & Leverage Consultants Where Needed: Participate in professional organizations and working groups to stay informed about regulatory updates and best practices. Consider engaging third-party consulting services with agencies that maintain close relationships with regulatory bodies to bridge internal gaps.

 

Conclusion

The evolving regulatory landscape under the new administration presents both opportunities and challenges for the MedTech and pharmaceutical industries. While deregulation efforts may ease compliance burdens, companies must remain vigilant regarding workforce reductions, evolving inspection protocols, and supply chain disruptions. To successfully navigate these changes, businesses should proactively enhance compliance measures, integrate technological advancements, and foster industry collaboration.

 

How We Can Help

Adapting to these regulatory shifts requires expertise and strategic planning. Regulatory Compliance Associates (RCA) and Nelson Labs offer industry-leading guidance in regulatory affairs, quality assurance, compliance, and laboratory testing. Our experienced advisors help organizations interpret evolving requirements, implement best practices, and successfully resolve complex regulatory challenges to bring safe and effective products to market.

 

 

To begin the Regulatory Compliance Associates and Nelson Labs scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].