Tag: medical devices
FDA Final Guidance on Mobile Medical Applications
Summary
On September 23, 2013, the FDA issued a guidance (“Final Guidance”) explaining how medical device regulations will be applied to medical mobile applications (MMAs).[1] The Final Guidance provides mobile application manufacturers with recommendations on how to comply with the regulatory and statutory requirements governing medical devices. The Guidance indicates that the FDA intends to limit its enforcement authority to only those mobile applications that operate as medical devices and pose a significant risk to patients if they fail to function as intended.
The Final Guidance outlines three categories of mobile applications (mobile apps) generally: (1) mobile apps that are not medical devices as defined under the Federal Food, Drug, and Cosmetic Act and are therefore not subject to FDA regulation; (2) mobile apps that may meet the definition of a medical device but over which the FDA intends to exercise enforcement … Read More »
The Perils and Promise of 3D Printing: Are DIY Life Sciences in Your Future?
With news that 3D printing (without question one of the coolest technologies to come down the road in quite some time) can be used to produce guns, we must now ask ourselves what other things might be built using a 3D printer. What about, say, a medical device? Or human tissue? Or body parts?
Some folks are batting around billion dollar numbers, imagining that the official market for these breakthroughs will be the big story in the years to come. And, to be sure, that “official” marketplace will be an important element in the new world of bio-mechanical printing. But as an IP lawyer, my first thought was this is going to be crazy.
So what is 3D printing, and why is it such a big deal? 3D printing is, as you might imagine from the name, a technology that permits three-dimensional … Read More »