Frequently Asked Questions

What are the 5 main goals of the ASCA pilot program?

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Compliance & Regulatory: MedTech
Guidelines & Standards

The ASCA Pilot goals are to: 

  • Streamline conformity assessment in device submissions 
  • Enhance the FDA’s confidence in test methods and results 
  • Decrease the need for additional information related to conformance with a standard 
  • Promote consistency, predictability, and efficiency in medical device review 
  • Serve as a least burdensome approach to conformity assessment 

Ultimately, the ASCA Pilot is intended to help the FDA ensure patients have timely and continued access to safe, effective, and high-quality medical devices.