The FDA’s expectations regarding the design of chemistry studies in support of medical device toxicology have been shifting rapidly. Over the past 12 months, new expectations have emerged primarily through feedback provided during submissions and pre-submission meetings, as the FDA has not yet released formal guidance on the application of ISO 10993-18. This evolving landscape has required laboratories to adapt quickly to ensure compliance and meet the regulatory demands.
This presentation will delve into the significant changes in chemistry study design that have occurred in response to feedback from the FDA. It will provide insights into how laboratories have adjusted their methodologies and processes to align with the FDA’s evolving expectations. Understanding these changes is crucial for anyone involved in the development and testing of medical devices, as it directly impacts the toxicological evaluation and safety assessments required for regulatory approval.
Key topics will include the latest trends in study design, the types of feedback commonly received from the FDA, and practical strategies for meeting these new expectations. Participants will learn how to design chemistry studies that not only comply with current FDA requirements but also anticipate future regulatory shifts.
The presentation will also highlight the importance of staying informed about FDA communications and leveraging pre-submission meetings to gain clarity on regulatory expectations. By doing so, laboratories can better prepare their study designs and avoid common pitfalls that could delay the approval process.
Attendees will gain a comprehensive understanding of the recent changes in FDA expectations for chemistry studies in medical device toxicology. They will learn how to effectively adapt their study designs to meet these new requirements, ensuring their medical devices are safe, compliant, and ready for market approval.