M. Bilek, Ph.D.
Medical Devices & Combination Products
Anastacia “Stacie” Bilek is a Director, Medical Devices and Combination products. She is responsible for multiple client projects involving the implementation of US regulatory strategies and submissions for the development and marketing of medical devices and combination products.
Stacie worked 11 years at FDA’s Center for Devices and Radiological Health (Silver Spring, MD) serving in pre- and postmarket roles. She brings an insider’s perspective on FDA expectations and decision-making.
As a scientific reviewer and Branch Chief in the Office of Device Evaluation, Stacie participated in the review of hundreds of pre-market submissions to FDA, such as 510(k)s, Pre-market Applications (PMA), Investigational Device Exemptions (IDE), and Requests for Designations (RFD) for combination products. As a Branch Chief and Division Director in the Office of Compliance, Stacie was responsible for a range of FDA postmarket and compliance activities including investigations, inspectional activities, Warning Letters, and recalls. In her final two years with FDA, she oversaw the creation of a new Division focused on premarket and labeling compliance for medical devices and participated in the Digital Health Steering Committee.
She has experience with a broad spectrum of therapeutic and diagnostic medical devices and combination products. She has a working knowledge of the technical, clinical, and regulatory aspects of diverse products, such as catheters, endoscopes, defibrillators, radiological imaging, orthopedic implants, drug-eluting stents, and wound dressings.
Stacie has a Doctorate in Biomedical Engineering from Tulane University (New Orleans, Louisiana, USA). Her dissertation research focused on cellular mechanics and tissue engineering. She obtained a Bachelor’s Degree in Biomedical Engineering from Boston University (Boston, Massachusetts, USA).