Skip to main content

FDA Issues New Draft Guidance on Medical Device Data Systems

On June 20, 2014, the Food and Drug Administration (FDA) issued draft guidance advising that the agency does not intend to enforce compliance with the regulatory controls that apply to medical device data systems, medical image storage devices and medical image communications devices, due to the low risk they pose to patients. The guidance, titled […]

| 3 min read

Ten Things to Know About the New Unique Device Identifier Rule for Medical Devices

Reprinted with the permission of the Record Reporter, originally printed as “The Future of Medical Recalls” on November 15, 2013. Many medical devices will soon carry a unique identity code, under a new rule recently published by the U.S. Food and Drug Administration (FDA). The FDA refers to this as the Unique Device Identifier (UDI) rule. A […]

| 6 min read
Former Partner

Summary of FDA Guidance on Mobile Medical Apps

Overview On September 25, 2013, the FDA issued its final guidance explaining how it plans to regulate mobile medical applications, or “apps,” under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The guidance clarifies which mobile apps[1] will be regulated by the FDA and who will be required to comply with the regulations. The […]

| 8 min read