As a scientific reviewer with the FDA in the Center for Devices and Radiological Health, I managed teams of clinicians, scientists, and engineers reviewing medical device marketing submissions and pre-submission inquiries. I also served as a vision science subject matter expert providing consulting reviews for ophthalmic devices, neurological devices, and combination products.

On the Retinal and Diagnostics Devices team in the Ophthalmics division, I developed expertise with the following regulatory processes:

Marketing Submissions & Regulatory Authority Interactions

  • 510(k)
  • De Novo
  • PMA
  • Breakthrough Device Designation
  • Q-Subs (Pre-submission Inquiries, Submission Issue Requests)
  • CAPA

Quality Management Systems & Risk Management

  • Quality System consensus standard (ISO 13485)
  • Risk management consensus standard (ISO 14971)
  • US Quality System Regulation (21 CFR 820)

Medical Device Software (including SaMD)

  • Ophthalmic diagnostic medical devices
  • Medical Image Management Processing Systems (MIMPS), etc.
  • Compliance with software development standards (e.g., IEC 62304, ANSI SW91, IEC 19770-2)
  • Compliance with FDA guidance recommendations (e.g., 2023 Premarket Software Guidance, Mobile Medical Applications, Interoperable Medical Devices, SaMD)

Cybersecurity

  • Compliance with consensus standards (e.g., NIST FIPS 140-3, IEC 29147, AAMI TIR57)
  • Compliance with FDA guidance recommendations (e.g., 2023 Premarket Cybersecurity, Postmarket Cybersecurity, Off-the-shelf Software)

Electromagnetic Compatibility/Electrical Safety

  • Compliance with FDA guidance recommendations (e.g., 2022 EMC)
  • Compliance with consensus standards (e.g., IEC 60601-1)

Biocompatibility

  • Compliance with FDA guidance recommendations (e.g., 2023 Use of ISO 10993-1)
  • Compliance with consensus standards (e.g., ISO 10993-1, ISO 10993-5, ISO 10993-10)