Skip to main content
RAPS Convergence 2023 Main banner
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.
Presentation Icons
Requires Pre-Registration or Sign-up
Requires Pre-Registration or Sign-up
Additional Registration Fee
Additional Registration Fee
Invitation Only
Invitation Only
Student Program
Student Program
Networking Opportunity
Networking Opportunity
RAPS Focus Area
RAPS Focus Area
Back
Evaluation ViewAttendees 29

Devices (includes Medical Devices and In Vitro Diagnostics)

Streamlining Conformity Assessment in Medical Device Review: the FDA's ASCA Program

Thursday, October 5, 2023
4:45 PM – 5:45 PM EDT
Location/Room: 513B
Intermediate Level
Description: The FDA strongly encourages the use of recognized consensus standards in medical device submissions. Capitalizing on the increasingly prominent role standards play in device development and review, the FDA has launched a new program: the Accreditation Scheme for Conformity Assessment, or ASCA. The FDA has awarded ASCA Accreditation to more than 90 test labs, which means FDA has confidence in their test methods and results. If manufacturers use ASCA testing, the conformity assessment aspects of their device's review will be streamlined and efficient. This session introduces participants to the ASCA program and its benefits, using real-world examples. The presentation and Q&A will also offer practical direction on how to compile a submission with ASCA testing.

Learning Objectives:

  • ..explain how the ASCA program works and how it streamlines conformity assessment in device review
  • ...cite ASCA standards and testing appropriately in a device submission