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Streamlining Regulatory Review with Consensus Standards

CLSI Regulatory Webinar

Streamlining Regulatory Review with Consensus Standards

Date: Wednesday, August 28, 2024 | 1:00 PM – 2:00 PMET  

Navigating the FDA device approval and clearance process can be daunting. However, the appropriate use of consensus standards can greatly reduce the burden for the conformity assessment elements of medical device submissions. By using declarations of conformity (DOC), particularly with FDA-recognized standards, device developers and manufacturers can streamline submission preparation. 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. 

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.

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Details

Date of Webinar: August 28, 2024

CLSI Regulatory Webinar Additional Details

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.  

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