Tuesday, 11 Jun 2024 (03:00 PM - 05:00 PM) Eastern Time (US & Canada)
1.0 RAC Credit
Standards solve problems. They are universally valued as important and valuable tools to support the design, manufacture, testing, and regulation of medical devices and, as such, play a key role in promoting safety and public health. When manufacturers rely upon FDA-recognized standards, submission documentation is less burdensome and more streamlined. This session will demonstrate the value of standards, explain how to cite them to maximize efficiencies, including in eSTAR, and introduce participants to the FDA's latest program to enhance standards' use: the Accreditation Scheme for Conformity Assessment, or ASCA. This discussion will also provide updates and insights to help regulatory professionals understand the FDA eSTAR program and how to cite standards using the eSTAR templates.
Click here to register today!
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Danielle Pennant
Chapter Events Specialist
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