New Rules for FDA Regulation of Lab Developed Diagnostic Tests (LDT)

Kelly Thomas

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Currently there are more than 4000 LDTs offered by hundreds of lab across the country subject to the LDT rules. Although FDA does not actively regulated LDTs, it has policies to encourage better testing and marketing of LDTs to consumers. Under the LDT rules, LDTs are reviewed based on the perceived risk and providers are expected to maintain records for validation, testing, and use of such tests. In the near future, FDA intends to apply enforcement discretion for the premarket approval requirements and quality system regulations, but these discretions may change in next few years.

Why should you attend:

FDA has expressed its desire to create rules to better regulate LDTs. This seminar will discuss the current rules and practical tips for being compliant to the current rules. The instructor will provide advice based on his extensive regulatory experience on the best and worst case scenarios for various kinds of LDTs under current regulations. This seminar is intended for general instructions to all LDT providers such as laboratories, clinics, physicians, hospitals, reimbursement experts, clinical trial users, and regulators who wish to have a better understanding of how FDA regulates LDTs.

Areas Covered in the Session: 

·Definition of LDTs and differences and similarities with other diagnostics

·Current FDA regulations and guidance documents

·Documentation required

·Quality systems currently applicable to LDT providers

·Labeling and marketing practices

Who will benefit:

·Senior management of LDT providers

·Project Managers

·Regulatory Vice Presidents, Directors and Managers

·Lab testing professionals

·Compliance professionals


·Attorneys – In-house or Outside Counsel

Webinar Events
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Kelly Thomas, Vice President, Americas Quality Operations

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk-based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.

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