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The FDA is aiming to develop additional documents and policies to help investigators and devicemakers understand Critical to Quality factors. Read More
With an eye toward ensuring patient safety, Malaysia’s Medical Device Authority has provided its thinking on how companies should report incidents involving medical devices. Read More
Olympus America, Fujifilm Medical Systems and Pentax’s Hoya unit had to submit postmarket surveillance studies to the FDA detailing how their duodenoscopes are reprocessed in healthcare facilities. Read More
Russia’s device authority is taking a strong stance against counterfeit and unregistered products, according to representatives at separate events in November. Read More
Despite a promised presidential veto, the U.S. Senate voted 52 to 47 Thursday in favor of a bill that contains a provision to repeal the medical device excise tax. Read More
The FDA’s Orthopedic and Rehabilitation Devices Panel will meet Feb. 19 to discuss Medtronic’s premarket application for the DIAM spinal stabilization system. Read More
Singapore’s Health Sciences Authority has updated its guidance on how manufacturers should notify the agency of modifications to registered medical devices. Read More
Gert Bos, a leading spokesman on behalf of European notified bodies, is leaving BSI Group to join global regulatory consultancy firm Qserve Group as executive director and partner. This change comes as device and diagnostics companies prepare for big changes in EU regulations. IDDM asked Bos about the timeline for the upcoming changes, as well as what companies can do to prepare. Read More
Theranos, a hot startup that recently received media scrutiny regarding its testing system, has been hit with two 483s, one of which takes the company to task for shipping an uncleared device. Read More
The China Food and Drug Administration has issued four guidelines that provide additional information for devicemakers awaiting good manufacturing practices inspections. Read More