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Lynette Zentgraft, a non-lawyer, has over 25 years of experience in food and drug matters, including seven years with the Food and Drug Administration (FDA). She has extensive experience working with medical device manufacturers on a range of premarket issues, including regulatory submissions (e.g., 510(k)s, IDEs, PMAs, HDEs, 513(g)s, presubmissions), device modifications, device classification and reclassifications, appeals/dispute resolution, and clinical trial requirements and inspections. Ms. Zentgraft also has significant experience with combination products, FDA’s regulation of software and digital health IT, laboratory developed tests, and human cell and tissue products (HCT/Ps).

While at FDA Ms. Zentgraft was a senior scientific reviewer in the Office of Device Evaluation in Center for Devices and Radiological Health. She was responsible for the review of premarket submissions, including 510(k)s, PMAs, IDEs, and HDEs.