About the Author
Proxima CRO Team
Taylor Lunsford, MGA
Regulatory Associate II
Taylor is fluent in Mandarin Chinese and has a strong background in medical interpreting and translating medical documents. Before joining Proxima, Taylor served in the Army as an intelligence analyst, instructor, translator and small-unit leader.

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.

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