ACHIEVE FDA LDT FINAL RULE COMPLIANCE
Are you ready for the FDA’s LDT Final Rule?
The FDA's April 2024 ruling is here, and it’s crucial to be prepared. Understanding your obligations, identifying compliance gaps, and building a strategic roadmap are key to staying on track. You need a clear path to compliance across your information systems, and LEAP is here to help you navigate every step.
The LEAP process provides a comprehensive 5-step approach to help laboratories meet the upcoming FDA compliance timeline for laboratory-developed tests, involving information gathering, technology analysis, gap identification, action planning, and implementation of the required remediation and adaptation measures.
HOW LEAP’S PROCESS HELPS YOU
BUILD YOUR COMPLIANCE PLAN TODAY
or email us at starthere@leapcg.com
Meeting deadlines and staying within budget depends on understanding the major gaps in your compliance posture. The FDA's timeline for enforcement discretion is strict and could change at any time. Identifying what needs to be done now will ensure you’re prepared when the time comes.
Stay Ahead of the Enforcement Timeline
To transition smoothly and meet FDA LDT medical device compliance obligations, it’s essential to build on your existing systems and processes. LEAP brings decades of experience in diagnostics, technology, and regulatory standards to ensure your systems are fully compliant.
Why You Need a Trusted Partner
Our consultants understand the unique challenges of regulated environments.
Deep Expertise
We’ve been helping laboratories like yours navigate FDA, GXP, and related standards since 2012.
Proven Track Record
We tailor our approach to fit your specific needs, ensuring your lab is ready for growth and transformation.
Scalable Solutions
Select Clients Leveraging LEAP's Expertise Today
Whether you’re starting from scratch or need to refine your current systems, LEAP offers a range of services to ensure your lab meets FDA compliance:
Tailored Solutions for Every Lab
CHANGE SCOPE ADVISORY ENGAGEMENT
Analyze your existing CLIA/CAP/NYS compliance and supporting documentation and systems.
FULL FINAL RULE
GAP ANALYSIS
A comprehensive review of your SOPs, systems, and compliance documentation against Part 11 requirement.
CHANGE SCOPE ADVISORY ENGAGEMENT
Tailored support, from high-level audits to hands-on remediation and bespoke solutions.
The time to act is now. The FDA's enforcement discretion can shift, and staying compliant is crucial to your lab's future. Ensure you meet all FDA obligations with LEAP’s expert guidance and 5-step process—start your journey to compliance today.
Act Now to Secure Compliance
BEGIN YOUR COMPLIANCE PLAN
Please feel free to reach out and share your thoughts on how the LEAP team can support your FDA compliance, or any other needs you may have.
Please include as much information as you think we may need to route your inquiry to the correct internal contact.