CLSI FDA Approval Webinar
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 premarket requirements and reduce the amount of supporting data and information that are submitted to the FDA.
Speakers from each area will each present information on the 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.
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Free
{{FormatPrice(nonMemberPrice)}} List PriceLearning 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.
Basic: Entry level. No prior knowledge of subject necessary.
CLSI is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program.
CLSI EP10IG
Free
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.
Basic: Entry level. No prior knowledge of subject necessary.
CLSI is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program.