February 16, 2019

Christina G. Kuhn

Christina Kuhn advises medical device, pharmaceutical, and biotech companies on a broad range of FDA regulatory strategy and compliance matters. She has experience with cutting-edge and complex medical technologies, including software and digital health products, oncology products, next-generation sequencing, diagnostics, and combination products.

Ms. Kuhn frequently helps multinational device manufacturers as well as start-up device companies navigate the premarket regulatory process, advising companies on regulatory classification, clinical development strategy, and agency interactions. She also has significant experience counseling medical device companies on postmarket compliance requirements, including those related to advertising and promotion, quality systems and manufacturing, medical device reporting, registration and listing, and recalls. She advises clients on responding to and resolving enforcement actions, such as FDA inspections and Warning Letters as well as Department of Justice investigations.

Articles in the National Law Review database by Christina G. Kuhn

LATEST LEGAL NEWS & ANALYSIS

TRENDING LEGAL ANALYSIS

Upcoming Legal Education Events

Thursday, February 21, 2019
Tuesday, February 26, 2019
Wednesday, February 27, 2019
Wednesday, February 27, 2019
Wednesday, February 27, 2019
Wednesday, February 27, 2019
Thursday, February 28, 2019
Wednesday, October 23, 2019