Practice Areas
“Focus like a laser, not a flashlight.” — Michael Jordan
Devices
Under FDA’s governing statute, the Federal Food, Drug, and Cosmetic Act (FDCA), a device is “an instrument, apparatus, implement, machine, contrivance, implant, or in vitro reagent” that “is intended for use in the diagnosis of a disease or…
Diagnostics
The Federal Food, Drug, and Cosmetic Act’s (FDCA’s) definition of “device” include “in vitro reagent” that “is intended for use in the diagnosis of a disease or other conditions . . . .” Thus, in vitro diagnostic products (IVDs) are considered devices…
Digital Health
Digital health technologies are rapidly changing how health care is delivered, and are helping individuals take control of their health. Many digital technologies have intended uses that fall under the scope of FDA’s jurisdiction, but the agency’s…
Genetics & Genomics
Genetic tests are intended to detect variants or mutations in the DNA of specific genes in individuals. Though many genetic tests have intended uses that fall outside of FDA’s jurisdiction, such as for ancestry, genetic tests are used…
Wellness
There is a risk of wellness products being subject to regulation by the FDA as devices. According to the FDA, general wellness products are low-risk products that promote a healthy lifestyle. Wellness products should not be subject to regulation if…
Advertising & Promotion
Advertising and promoting your device, diagnostic product, genetic or genomic test, wellness product, or digital health product with certain claims or images may lead the FDA to deem your product to be “misbranded.” Improper claims may…