About

MELISSA HALL, a seasoned medical device regulatory expert with over 10 years of experience, has spent most of her career in the premarket space of the Food and Drug Administration where she's held various roles such as lead reviewer, assistant director, consumer safety officer, and policy analyst.

She has reviewed all premarket submission types and has specific expertise in the orthopedic space. As a consumer safety officer she served as an industry educator of the premarket regulatory processes. As a policy analyst, she served as a regulatory expert for the center addressing complex regulatory issues for all medical device types and ensuring laws, regulations, and guidances were applied consistently across the center. Prior to her career at the FDA, she was a patent examiner at USPTO.

As a consultant, she is passionate about advancing public health by assisting the medical device community in various efforts to navigate the complex regulatory process and strategize the best path that aligns with their business goals. She shares her experience developing regulatory strategies and submissions for a broad range of devices including SaMDs, hearing aids, orthopedics, dental, etc.

She earned a bachelor's degree in biology from the University of Maryland Baltimore County and a Master of Science, Biomedical Engineering from New Jersey Institute of Technology.