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2024 Edward Bennett Rosa Award
AWARD CITATION
Ms. Phelps is recognized for her outstanding leadership in developing a groundbreaking conformity assessment program for medical devices sold in the U.S. The FDA's Center for Devices and Radiological Health Accreditation Scheme for Conformity Assessment (ASCA) Program plays a vital role in building consumer confidence by ensuring that medical devices meet standards requirements that ensure product quality, safety, and compliance with standards and regulations. With Ms. Phelps' expertise, the FDA successfully created, piloted, and finalized the new program. Implementation of the program has led to substantial reductions in product defects, increased production rates, and cost savings.