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.