Principal Medical Device Consultant
As an ex-FDA Medical Device Reviewer, Dr. Yan has reviewed many types of IVD medical device applications including pre-submissions, 510(k), De Novo, and post-market allegations. She led multiple 510(k) and De Novo on several hematology devices, such as:

• Differential cell counter (e.g., K190294)
• Automated hemoglobin system (e.g., K181751)
• Fecal occult blood test (e.g., K191147)
• Erythropoietin assay (e.g., K183088)
• Heparin and Direct Oral Factor Xa Inhibitor Drug Test System (DEN190032)

Dr. Yan also managed the 513(g) program for device determination and device classification by providing scientific, regulatory, and policy guidance and oversight. She reviewed and concurred over 300 submissions across the center with all device types. She led the interpretation and implementation of new and complex policy and guidance, examples include:

• Software Functions and Mobile Medical Applications
• Multiple Function Device Products
• Medical Device Data Systems
• General Wellness

With more than 10 years combined experience at FDA, academia, and MedTech industry, Dr. Yan provided medical device consulting support to projects in translational research funding programs including TABA Needs Assessment, NHLBI Catalyze, and ARPA-H. She provides strategic regulatory pathways, manufacturing, and clinical studies.

Dr. Yan has her Ph.D. in biology from Johns Hopkins University and dissertation research at NCI on immuno-oncology. Dr. Yan performed immuno-toxicology post-postdoctoral research at CDER/FDA.