Dr. Chen

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
  • 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.

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