Principal Medical Device Consultant
ex-FDA device reviewer
Dr. Chen has more than 15 years’ experience combined at FDA as a reviewer and team leader at CDRH, FDA and industry experiences at Boston Scientific, Endocare, Varian Medical Systems, Genetron Health and MicroDiag Biomedicine.Technical Expertise

• Knowledge and experience in regulatory requirements and pathways for
  premarket review including 510(k), PMA, IDE, HDE and De Novo.
• Reviewer of premarket PMA review team and oversee medical device
  post-approval and post-market surveillance studies.
• FDA’s regulatory strategies for medical devices.
• Real-world study in medical device evaluation.
• Combination (Drug-Device) products regulation.
• Medical device risk management.
• Clinical evidence requirements for medical device approvals by FDA.
• Clinical evaluation to support the registration of new medical device
  products.
• Knowledge and experience in medical device classification/regulations and
  review process.
• Knowledge and experience in FDA available resources to help prepare the
  premarket submissions including 513(g) Device Classification Request,
  Pre-Submission (Q-sub), Breakthrough Devices Designation Application.
• Knowledge in FDA’s Medical Device Compliance Programs.