NANCY STADE brings 17 years’ experience at the U.S. Food and Drug Administration (FDA) to her practice, offering clients wide-ranging counsel on FDA law with deep knowledge in the areas of medical device and combination product regulation. At the FDA, Nancy served in a variety of senior positions, including Deputy Director for Policy at the Center for Devices and Radiological Health, where she led the development and implementation of FDA’s device regulatory policy.

While at FDA, Nancy:

Shaped policy concerning multiple complex and novel devices, including mobile medical applications and other Health IT devices, companion diagnostics and combination products
Initiated a pilot program to allow parallel review by FDA and CMS of innovative technologies
Oversaw the implementation of all FDASIA device-related provisions, including key provisions related to Unique Device Identification, risk-based classification of devices and modifications to 510(k) devices
Oversaw the Office of the Ombudsman, providing strategic input on Center-level 10.75 appeals related to device jurisdiction, substantial equivalence, and 510(k) and PMA data requirements
Represented CDRH in two proceedings invoking the Dispute Resolution Panel to review PMA denials