CLSI Regulatory Webinar
Streamline the FDA Approval Journey: A Panel Discussion with the FDA, CLSI, and Abbott Laboratories
Date: Wednesday, August 28, 2024 | 1:00 PM – 2:00 PM ET
The appropriate use of consensus standards can greatly streamline FDA medical device submissions and reduce the burden for the conformity assessment elements. With appropriate use of FDA-recognized consensus standards, developers of devices and LDTs can submit declarations of conformity (DOC) to meet some premarket requirements and reduce the amount of supporting data and information that are submitted to FDA.
Speakers from each area will each present information on development and/or use of standards from their perspective:
- Clinical and Laboratory Standards Institute (CLSI), for standards development process and standards available to industry.
- FDA, for the appropriate use of standards.
- Abbott, for the industry perspective on participation in standards development.
Price: Free
Speakers:
Barb Jones, PhD, CEO, CLSI
Terry Woods, PhD, Director, Division of Standards and Conformity Assessment (DSCA), FDA
Vicki Petrides, MS, Quality Program Manager, Abbott
Earn 1.0 P.A.C.E.®️ credits. The on-demand recording for this webinar will be available on Friday, August 30.
Details
Date of Webinar: August 28, 2024
CLSI Regulatory Webinar Additional Details
Learning Objectives:
- Identify how the use of FDA-Recognized Standards can reduce the documentation burden of regulatory submissions.
- Determine how to use consensus standards effectively, including the submission of a Declaration of Conformity to the FDA.
- Summarize how participation in standards development is essential to ensuring that consensus standards incorporate regulatory needs.
CLSI is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program.