Author: Brandon Miller

Regulatory Compliance Associates® will be at MD&M East in New York City May 20th- 22nd. Join us in the Sotera Health booth #838 with Nelson Labs and Sterigenics to get answers for any of your medical device quality, regulatory, compliance, lab testing, and sterilization needs.

To schedule a meeting with us, please fill out the contact us form at the bottom of the page email us at [email protected].

We will also be offering free a presentation in the Tech Theater.

Tech Theater Presentation:

Topic: ISO 10993-1: Key update on the new revision of this critical standard

Speaker: Thor Rollins, VP Global Segment Leader, Medical Device, Nelson Labs

Tech Theater, Booth 878

Tuesday, May 20, 2025

1:30 – 2:15p.m. PT

This presentation will delve into the latest updates to ISO 10993-1, the cornerstone standard guiding biocompatibility assessment for medical devices. The most current updates out of the ISO meetings in October, introduces a more dynamic, risk-based framework. These changes carry implications for device manufacturers and regulatory professionals running biocompatibility studies. In the presentation you will learn:

  • Key updates include a stronger emphasis on a risk-based approach, moving away from prescriptive testing protocols.
  • New emphasis on chemical characterization, where the new ISO 10993-1 improves the ability to predict device safety and mitigate potential toxicological risks.
  • The incorporation of endpoint-specific risk assessment such as changes on devices requiring genotoxicity evaluations.
  • End of life evaluations

Attendees will gain insights into the practical implications of these changes, including how to adapt biocompatibility testing strategies, documentation practices, and regulatory submissions. This presentation will also discuss the broader impact of these updates on global harmonization of biocompatibility standards and their alignment with other regulatory frameworks, helping professionals ensure compliance while enhancing product safety and innovation.


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To begin the Regulatory Compliance Associates 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].

Join Regulatory Compliance Associates (RCA) in Washington, DC May 15th-16th for the FDLI Annual Conference to connect with our consulting Experts to learn how we can provide you with a complete solution for any of your projects. Together we can confidentially discuss your client and can prepare compliance enforcement solutions to help ensure the safety of their products, process, and organization as a whole.

 

About the FDLI Annual Conference

Our conference provides a unique opportunity to delve into the complex legal, regulatory, compliance, and policy issues currently impacting the FDA-regulated industry. Join experts from federal government, industry, the private bar, non-profit organizations, patient and consumer advocacy groups, consulting organizations, and the world of academia as the FDLI community meets for the event of the year!

Conference Highlights:

  • Hear FDA’s strategic priorities directly from the FDA Commissioner, Chief Counsel, Center Directors, and other key leaders within the agency
  • Gain in-depth knowledge of each FDA Center by attending consecutive Center Director sessions scheduled to maximize attendee opportunities
  • Join high-level colleagues in food and drug law to hear different viewpoints, shape policy, and advance understanding
  • Select from over 30 breakout sessions covering the latest in legal, regulatory, compliance, policy, marketing, and related issues to enjoy targeted sessions for your key interests
  • Learn from more than 100 well-known officials and experts
  • Hear about the Top Cases in Food and Drug Law
  • Network and build relationships with seasoned legal, regulatory, compliance, policy, and government professionals

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As regulatory processes evolve, the Knowledge-Aided Assessment and Structured Application (KASA) system is set to transform FDA application reviews through automation and structured data analysis. Designed to enhance efficiency and consistency, KASA aims to supplement traditional narrative-based reviews with a data-driven approach to regulatory decision-making.

 

What is KASA?

KASA is a data-based review tool that will allow the FDA to assess the Quality portion of applications more effectively by leveraging structured data elements. This system is expected to provide standardized, automated quality risk assessments, helping streamline the evaluation of NDAs, ANDAs, and BLAs.

 

Potential Benefits of KASA

  • Improved Efficiency: Automates portions of the review process, reducing manual workload for FDA reviewers.
  • Enhanced Consistency: Establishes a standardized framework for application assessments and a collaborative multi-disciplinary review, minimizing variability in regulatory decisions.
  • Mitigation of Delays: May help counteract potential slowdowns due to FDA workforce reductions, ensuring timely reviews despite resource constraints.

 

Challenges and Uncertain Timeline

Although the FDA had scheduled a webinar to discuss KASA’s implementation, it was postponed until further notice due to recent administrative shifts. The future rollout of KASA will depend on FDA leadership priorities and resource allocation under the new administration.

 

What This Means for Industry Stakeholders

Companies submitting regulatory applications should stay informed about KASA developments. As the system moves forward, ensuring structured, well-organized data submissions will be crucial for efficient regulatory review processes.

 

While the timeline for KASA’s full implementation remains unclear, its eventual adoption promises a more streamlined, consistent, and technology-driven approach to FDA application reviews.

 

Stay Ahead with RCA

For expert guidance and tailored solutions in navigating complex FDA requirements, contact RCA today to secure compliance, streamline approvals, and achieve regulatory success with confidence.

 

To begin the Regulatory Compliance Associates 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].

 

Regulatory Compliance Associates’ (RCA) Susan Schniepp, Distinguished Fellow at RCA and Chair of the Board of Directors at the Prenatal Drug Association (PDA) leads this training in collaboration with the FDA through the Compounding Quality Center of Excellence and the PDA.

 

Course Description

Learn the fundamentals of establishing an effective Quality Management System (QMS) and building a culture of quality within a facility. This training course includes information about the comprehensive QMS approach to quality, the critical role of senior leadership, and building a quality culture mindset throughout the organization. The course will also explore the concepts of knowledge management, quality risk management, and data integrity. Practical activities will include the use of case studies, responding to inspectional observations and warning letters, conducting quality culture assessments, and evaluating data integrity risks.

 


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Learning Objectives

Upon completion of this training course, the attendee will be able to:

  1. Describe the impact of quality and the Quality Unit (QU) on all areas of operation
  2. Define the roles and responsibilities of the QU
  3. Describe the foundations of an effective QMS
  4. Describe the critical role of senior management in QMS
  5. Explain the concept and basic principles of product knowledge and process understanding
  6. Explain the basic principles of Quality Risk Management (QRM)
  7. Describe how internal audits and external inspections can support an effective QMS
  8. Explain the principles and best practices surrounding data integrity
  9. Explain the principles of a Quality Culture mindset

Practical activities will include case studies, inspectional observation and warning letter responses, quality culture assessments, and data integrity risk evaluations.

Regulatory Compliance Associates® will be exhibiting at INTERPHEX in New York City from April 1st–3rd 2025 with Sterigenics and Nelson Labs. Stop by booth #1753 to meet experts from each team to learn how we can provide you with a complete solution for any of your projects. Together we understand your business and are prepared to discuss solutions to your regulatory, quality, compliance, sterilization, and lab testing needs to help ensure the safety of your product and process.

 


About Interphex®

For 40+ years, INTERPHEX has been the premier pharmaceutical, biotechnology, and medical device development and manufacturing event where you can “Experience Science through Commercialization”.

Based in New York, INTERPHEX brings over 10,500 global industry professionals and 620+ suppliers together to “Learn It, Experience It, Procure It” through a unique combination of our no-cost technical conference, exhibits, demonstrations, partnering opportunities, and networking events to leverage quality, efficiency, and cost-effectiveness in today’s ever-changing global market.

 

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

 

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].