FDA’s Regulation for Molecular Diagnostics

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

"Todd Graham is a masters-level bench scientist and medical technologist with a host of experience in both the clinical diagnostics and biotechnology fields"

How to choose the different tracks of the process


The FDA process for molecular diagnostics is multifaceted and complex. The FDA gives regulatory discretion to some tests, while mandating strict regulatory approval for other tests. The process can appear contradictory to the outside eye, but there is a logic to this process. This webinar will explain the ins and outs of this process, how to choose the different tracks of the process, and the regulatory requirements for each part of the process. By the end of this webinar, you should be aware of the various options of the process and select which one you should chose to move forward in this process.

Areas Covered

This webinar will help you learn how to navigate the regulatory process. The webinar will include the following critical information you will need:

•      What is a molecular diagnostic?
•      What are the different regulatory tracks for molecular diagnostics?
•      How do companion diagnostic regulations work?
•      How does laboratory directed testing regulations work?
•      How does the 510(k) pathway work?
•      How does the PMA pathway work?

Who will Benefit

•      Bench Scientists
•      Quality Assurance
•      Research Scientist
•      Business Development

Industries who can attend

This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel

Speaker Profile

Todd Graham

Todd Graham is a clinical laboratory scientist for a large hospital system in the New York Tri-State Area as well as a scientific consultant for Fortune 500 biotechnology firms, healthcare systems throughout the world and R1 Research Level Universities. During his time as a clinical laboratory scientist in his current role, he has improved sample workflow and improved laboratory quality and sample turnaround time while expanding laboratory services to vulnerable health populations in the New York area. He has also provided outreach to the local community by serving as a mentor to students training in clinical laboratory science, as well as the scientific community by serving as a technical resource for his peers in the laboratory.

Through his work as a consultant, he has worked to improve the spread of key technical information in a variety of mediums. Todd has written a number of market research reports used by Fortune 500 biotechnology firms in strategic planning, and led webinars on key quality issues that impact the biotechnology community. He has served R1 Research Level Universities by advising them on strategic technology transfer opportunities, and has been called upon as a key knowledge leader internationally for the biotechnology industry.

Todd Graham graduated in 2006 with a MA in Biology at Queens College (City University of New York) after conducting published research in Molecular Evolution in the laboratory of Dr. Stephane Boissinot. He graduated as a Dean’s List student and James Dickson Carr Scholar from Rutgers University in 2001 with a BS in Biotechnology, where he continues to mentor Biotechnology students. He is a member of the Society for Laboratory Automation and Screening. He is also licensed as a Clinical Laboratory Technologist in New York State and is certified in Molecular Diagnostics by the American Society for Clinical Pathology.

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