Keith Barritt

Keith A. Barritt is a principal in the Washington, D.C., office of Fish & Richardson. His practice is primarily focused on all aspects of trademark law as well as all aspects of medical device regulation by the FDA, including obtaining marketing authorization for medical devices, use of new devices for investigational purposes, and import and export issues. Barritt has prepared and filed dozens of 510(k) pre-market notifications, ranging from innovative lasers to software-based surgical devices. He advises clients on issues involving quality system regulations, device labeling, medical device reporting obligations, recalls, device listing, establishment registration, and import/export regulations. To contact him, visit


  • Medical Device Trademarks 101: Protecting Your Good Name

    On average, trademarks account for about one-third of U.S. corporate value. A good brand name can boost sales, help weather negative publicity, and facilitate overseas marketing. What goes into a good name for a medical device, taking steps to protect that name, and complying with FDA regulations are important considerations in maximizing a new medical device's return on investment.

  • 3 Lessons: FDA/FTC Enforcement Against Mobile Medical Apps

    Despite FDA’s deregulatory shift to encourage the development of mobile medical apps and other digital devices, the U.S. government has pursued enforcement action against mobile medical apps over the past few years, and has taken other action when manufacturers of wireless devices face cybersecurity issues. While rare, such public enforcement actions serve as a reminder that there are still limits to what can be lawfully marketed.

  • How To Build A 510(k) Application For Your Mobile Medical App

    Although the FDA has taken substantial steps to deregulate many mobile medical apps, there will always be some apps beyond that safe harbor — such as fetal heart rate monitors and acupuncture point locators — that are regulated as medical devices. This article discusses what FDA guidelines software developers should consider as they are writing code and building their apps.

  • How To Avoid FDA Regulation Of Your Mobile Medical App

    There seems to be no escaping the ubiquitous onslaught of wearable sensors designed to monitor and measure all kinds of physical parameters.  Often, these devices have Bluetooth connections to your smartphone to allow for greater processing and storage of data.  Determining when these products are subject, as medical devices, to regulation by the U.S. Food and Drug Administration (FDA) is a very hot topic, both at the agency and in the industry.