Penn Avenue Law & Policy

FDA Strategies for Cutting Edge Technologies.

The FDA process may seem straightforward on paper. The reality is frequently full of twists and turns that experienced counsel can help you navigate.

Practice Areas

Under FDA’s governing statute, the Federal Food, Drug, and Cosmetic Act (FDCA), a ...

The Federal Food, Drug, and Cosmetic Act’s (FDCA’s) definition of “device” include...

Digital health technologies are rapidly changing how health care is delivered, and are...

Genetic tests are intended to detect variants or mutations in the DNA or specific genes...

There is a risk of wellness products being subject to regulation by the FDA as devices...

Advertising and promoting your device, diagnostic product, genetic or genomic test, ...