ARTICLES BY KEITH BARRITT
Medical Device Trademarks 101: Protecting Your Good Name4/13/2016
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 Apps1/14/2016
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 App10/6/2015
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 App7/7/2015
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.