Principal IVD and Software Consultant
With more than 15 years combined experience at FDA and MedTech Industry, Dr. Li had reviewed and drafted a large number of regulatory submissions, including Q-Subs, IDE, BTD, De Novo, 510(K), PMA. As a Senior Lead Premarket Reviewer at FDA/CDRH, Dr. Li had extensive experiences in the following medical device areas:

• Premarket review of NGS CDx Oncopanels
• Establishing the regulatory framework for NGS tumor profiling panel for solid tumors and 3rd party review program
• Biomarker strategy for precision oncology drug trial
• Minimal Residual Disease (MRD) tests
• WGS and WES based genomic tests
• Clinical validation strategy of Multi-Cancer-Early-Detection (MCED) tests
• Genomic databases, digital pathology and other AI-based Software Devices

Dr. Li’s consulting focuses on global clinical and regulatory strategy for In Vitro Diagnostics (IVDs), precision oncology therapeutics, digital health products, and Software as a Medical Device (SaMD).

Dr. Li has a PhD in Human Genetics and RAC Certificate.