We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
In the wake of more than 5,000 adverse events reports, including four deaths, the FDA says it plans to communicate next steps it plans to take on Bayer’s Essure contraceptive implant by the end of next February. Read More
The FDA is re-proposing classifying in vitro diagnostic devices for Bacillus species detection into Class 2 with special controls, a move the agency says would help assure the safety and effectiveness of the devices. Read More
A Texas man who owned two Houston-area durable medical equipment companies must serve five years and three months in prison and pay $1.96 million in restitution for his role in a scheme to defraud Medicare, the U.S. Department of Justice announced. Read More
A bipartisan group of 44 freshmen members of Congress is urging House Speaker Paul Ryan (R-Wisc.) to include medical device tax repeal provisions in a larger legislative package by the end of the calendar year. Read More
The Irish Medical Devices Association has laid out an ambitious set of priorities it hopes to see acted on by the next government to maintain the country’s competitiveness in the medtech sector. Read More
Shrugging off complaints that it is hindering innovation, the FDA is looking into whether five companies are selling unapproved diagnostic tests. Read More