Nine years ago, Congress passed an important piece of legislation requiring unique medical device identifying numbers on all medical devices. The law requires manufacturers to label each medical device,...
The FDA’s Center for Devices and Radiological Health (CDRH) has been incredibly busy lately. Earlier this week, the CDRH announced the completion of a project to analyze past medical...
What does a device manufacturer do when it wants to make changes to its products? Before now, that was unclear; but, the FDA issued a draft guidance that aims...
The U.S. Food and Drug Administration (FDA) recently announced a reduction in fees for new medical device applications. The FDA hopes reducing the cost of applications will help encourage...
One of the quickly emerging fields in medical innovation is 3D printing, and DePuy Orthopedics (a subsidiary of Johnson & Johnson) recently announced a partnership with 3D printing giant...
The UK’s exit from the European Union has left many questions regarding how the country will conduct business with other European countries. For the medical device industry, this question...
The Food and Drug Administration (FDA) has released a draft guidance on medical device availability, compliance, and enforcement. The draft guidance will help device manufacturers understand the process the...
The Food and Drug Administration (FDA) has approved an unusual device that is designed to remove food directly from the stomach and deposit it into the toilet. While the...
Health Canada released a statement warning physicians and patients of the dangerous complications associated with Essure, a permanent birth control implant. The device, manufactured by Bayer A.G., has led...
While the FDA has set strict guidelines for the approval of medical devices, a recent study from researchers at Northwestern University’s Feinberg School of Medicine found that several high-risk...
