POCs, IVDs and LDTs — Way More than Alphabet Soup – Webinar Recording/Transcript
What pathway should you consider for your premarket submission? 510(k)… De Novo… Premarket approval (PMA)… or emergency use authorization (EUA)?
Which one will work best for your device? Have you prepared for the application and data requirements?
Determining the best system to move these technologies forward can be complex.
This presentation will arm you with the knowledge you need to tackle the FDA’s premarket approval and clearance processes around in vitro diagnostics (IVDs), laboratory developed tests (LDs) and other medical devices. These point-of-care products require unique interactions with the FDA and it’s important to determine how to best navigate these regulatory expectations from the start.
FDA experts Seth Olson and Susan D. Tiedy-Stevenson will share advice about FDA applications and data requirements. Through their experienced perspectives, you’ll gain insights on clinical laboratory improvement amendments (CLIA) categorizations and waivers, along with the ways the Verifying Accurate, Leading-edge IVCT Development (VALID) Act will change testing. We’ll also consider how software can be deemed a medical device and strategies around FDA pre-submission meetings.
Key Presentation Takeaways:
- FDA Premarket Submission Considerations
- 510(k), De Novo, PMA and EUA considerations
- The effect of the newly proposed VALID Act
- The definition of a medical device
- The FDA’s medical device classification and regulations
- Information and data requirements
- The FDA’s role in CLIA classification and waivers
- Software as a medical device
- Standard approaches to 704(a) requests
- FDA pre-submission programming and strategies for informal modes of communication
- Modes of communication: email, phone and in-person
The prospect of a premarket FDA submission for point-of-contact technologies can be daunting. FDAnews can make it easier. Join us to discover the best ways to move forward through this complicated process and ensure your product has the best chance of FDA approval.
Meet Your Presenters
Seth Olson helps clients maneuver the FDA’s complex medical device and technology regulations. As a former regulatory counsel at the Center for Devices and Radiological Health (CDRH) at the FDA, Olson brings his regulatory experience on both medical device premarket review and post-market compliance issues. He has advised medical device clients in relation to premarket submissions, advertising and promotional issues, FDA actions, and internal quality and regulatory investigations. Olson earned a J.D. from The George Washington University Law School and an MBA from the University of New Hampshire. He also studied biology at Brigham Young University.
Susan D. Tiedy-Stevenson assists clients in obtaining FDA marketing approvals and clearances for diagnostic tests and medical devices. She helps them through the entire life cycle of product development, from FDA quality system requirements to clinical and analytical development to post-marketing strategies. Tiedy-Stevenson is attuned to the needs of large corporations and start-up companies when formulating practical solutions to address FDA regulatory requirements. Her experience has given her deep insights into the FDA’s biologics and medical device regulations of in vitro diagnostic (IVD) assays and related instruments, accessories, laboratory developed tests, and drug companion diagnostics. She also assists clients concerning FDA regulation of non-IVD medical devices, including diabetes diagnostic and treatment devices and standalone software diagnostic applications.
Who Will Benefit
- Medical device companies
- Companies that market IVDs, point-of-care technologies, and companion diagnostics
- Medical device regulatory affairs professionals
- Medical device attorneys
- Medical device company executives
- Submissions and approvals professionals
- Commercial operations professionals
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Sept. 30, 2020