Streamline the FDA Approval Journey: A Panel Discussion with the FDA, CLSI, and Abbott Laboratories

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. This webinar will feature a live Q&A discussion.

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.

Wednesday, August 28, 2024 | 1:00 PM ET

Earn 1.0 P.A.C.E.®️ credits.

Learning Objectives:

1. Identify how the use of FDA-Recognized Standards can reduce the documentation burden of regulatory submissions.
2. Determine how to use consensus standards effectively, including the submission of a Declaration of Conformity to the FDA.
3. Summarize how participation in standards development is essential to ensuring that consensus standards incorporate regulatory needs. 

Agenda
Introduction and CLSI’s Standards Development Process, Barb Jones, PhD 

FDA-Recognized Standards and Declaration of Conformity, Terry Woods, PhD 

Participation in Standards Development, Vicki Petrides, MS 

Q&A Discussion | All Panelists, Moderated by Barb Jones, PhD 

CLSI is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program.