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.
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