June 20, 2024

From LDTs to IVDs: Navigating the New Regulatory Landscape

Join us for an insightful webinar covering the evolution and current state of Laboratory Developed Tests (LDTs). We will briefly review the FDA's discretionary enforcement practices over the years to compare them with the newly established regulatory landscape.

The session will delve into the new LDT rule, exploring its implications for laboratories to move their LDTs into the FDA regulated environment of in-vitro diagnostics (IVDs), identifying exempt devices, and discussing continued enforcement discretion.

Key topics will include a detailed timeline for compliance, an overview of FDA requirements such as quality systems and regulatory submissions, and practical advice on initiating processes from quality, regulatory, and clinical perspectives.

Attendees will gain an understanding of how to navigate the new regulatory landscape and effectively move forward in this evolving field.

Specifically, This webinar will cover:
  • Overview of LDTs: Participants will gain a comprehensive overview of the history, evolution, and current landscape of Laboratory Developed Tests.
  • FDA Enforcement: Insight into the history of FDA discretionary enforcement related to LDTs.
  • New LDT Rule Implications: Clarity on the new LDT rule, including its impacts on LDT laboratories, exempt devices, and continued enforcement discretion.
  • FDA Compliance Requirements: Detailed knowledge of the FDA requirements for LDT laboratories to navigate quality systems and regulatory submissions, including Q-sub/pre-submission meetings, 510(k), and de novo applications.
  • Practical Ways to Move Forward: Recommendations on the appropriate timelines and strategies from quality, regulatory, and clinical perspectives.

Watch the webinar

From LDTs to IVDs Navigating the New Regulatory Landscape
Who should attend?
  • Medical Device Executives
  • Product Development Engineers and Management
  • Quality Professionals and Management
  • Regulatory Affairs Professionals and Management
Register Now  

Hosted by

Etienne Nichols

Medical Device Guru,
Greenlight Guru

Carol Buchert
Carol Buchert

Director of Regulatory and Quality Affairs,
MDC Associates

Sruthi Sundaram
Sruthi Sundaram

Regulatory Affairs Specialist,
MDC Associates

Greenlight Guru logo

About Greenlight Guru

Greenlight Guru is the leading cloud-based platform purpose-built for MedTech companies. The end-to-end solution goes beyond traditional QMS needs by integrating cross-functional teams, processes, and data throughout the entire product lifecycle so device makers can proactively overcome execution gaps, streamline compliance, and accelerate market success.

Greenlight Guru’s platform is used by organizations across the globe that are replacing their disjointed, legacy tools and solutions to bring life-changing products to people faster, and with less risk.

Visit our homepage to learn more.


About MDC Associates

MDC Associates, Inc. is a leading CRO, Regulatory Affairs, and Quality Systems consulting firm, specializing in providing comprehensive services to medical device and in-vitro diagnostic manufacturers. For over 30 years, MDC has built a strong reputation for guiding innovative diagnostic technologies through the complex regulatory and clinical processes to achieve market clearance. With teams nationwide, MDC works closely with clients and clinical trial sites to secure approvals from the U.S. FDA and other health organizations. 

In collaboration with Greenlight Guru, we harness the power of their eQMS, ensuring maximum compliance and unlocking its utmost potential.

Visit our partnership page to learn more.

Featured In