Janice M. Hogan

Widely recognized as a leader in FDA regulation of devices, Janice leverages her technical background to help companies with cutting-edge technologies navigate and optimize the FDA approval process.

Janice focuses on FDA regulation of high-tech products in women's health, diagnostics, neurology, cardiovascular, and orthopedics. She has assisted companies to obtain "first-of-a-kind" FDA approvals, providing guidance on regulatory strategy, clinical study design, advisory panel proceedings, and tools to expedite product approval.

Janice brings her lifelong passion for science and innovation to bear in her client advocacy. Through her extensive experience representing companies in a wide range of FDA interactions, Janice has been at the forefront of several of the most innovative medical device approvals, including the first successful FDA/Centers for Medicare and Medicaid Services parallel review project, as well as first-in-class approvals for devices used in treatment of breast cancer, diabetes management, obesity, spinal surgery, and neurology, as well as a variety of drug/device combination products. Janice also has substantial experience using newer FDA approval mechanisms such as the de novo process to reduce review time and bring products to market earlier, accelerating patient access.