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WCG FDAnews
FALLS CHURCH, Va. (PRWEB)
September 16, 2020
POCs, IVDs and LDTs — Way More than Alphabet Soup:
What Medical Device Professionals Need to Know for Premarket Approval
An FDAnews Webinar
Wednesday, Sept. 30, 2020, 11:00 a.m.-12:30 p.m. EDT
https://www.fdanews.com/pocsivdsldts
Planning to approach the FDA with a premarket submission for a point-of-care technology? Which pathway will work best? Is the team prepared for the application and data requirements?
This webinar will provide the knowledge needed to understand the FDA’s premarket approval and clearance processes around in vitro diagnostics (IVDs), laboratory developed tests (LDs), and other medical devices.
FDA experts Seth Olson and Susan D. Tiedy-Stevenson will share advice about FDA applications and data requirements. Through their experienced perspectives, attendees will 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.
During this webinar, we will cover:
● FDA Premarket Submission Considerations
a. 510(k), De Novo, premarket approval (PMA) and emergency use
authorization (EUA) considerations
b. The effect of the newly proposed VALID Act
● Medical Device Definition and Classification
a. The definition of a medical device
b. The FDA’s medical device classification and regulations
c. Information and data requirements
d. The FDA’s role in CLIA classification and waivers
● Considerations for Point-of-Care Technologies
a. Software as a medical device
b. Standard approaches to 704(a) requests
● Communicating with the FDA
a. FDA pre-submission programming and strategies for informal modes of
communication
b. 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.
Interested in registering multiple sites?
Call 888.838.5578 in the U.S. or +1 703.538.7600 globally
to learn about our special multisite discount.
Webinar Details:
POCs, IVDs and LDTs — Way More than Alphabet Soup:
What Medical Device Professionals Need to Know for Premarket Approval
An FDAnews Webinar
Wednesday, Sept. 30, 2020, 11:00 a.m.-12:30 p.m. EDT
https://www.fdanews.com/pocsivdsldts
Tuition:
$287 per site
Easy Ways to Register:
Online: https://www.fdanews.com/pocsivdsldts
By phone: 888.838.5578 or 703.538.7600
About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations
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