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India’s health ministry has given the go-ahead for 28 clinical trials, 14 of which are international studies — a continuation of the rebounding number of studies in the country. Read More
China’s medical device authority released a draft regulation outlining how it will accredit medical institutions that conduct clinical trials for devices. Read More
Sponsors hoping to gain de novo status for new medical device accessories should prepare submissions closely mirroring those for stand-alone devices, the FDA says. Read More
The South Korean government has drafted a regulation that would expand its medical device tracking system to include 24 additional types of products. Read More
House and Senate lawmakers are teaming up on an overhaul of FDA device procedures, including expanding the use of third-party quality audits. Read More
Important details on unique device identification, such as transition times, are missing from the EU’s draft medical device regulation, a major industry group says. Read More
In a 46-page draft guidance released Jan. 26, the U.S. FDA clarified a 2013 final rule that specifies how combination product manufacturers should meet both device and drug quality regulations and implement streamlined quality systems. Read More
Beginning Jan. 26, labelers of implantable, life-supporting and life-sustaining devices that are not Class III were able to register with the FDA’s Global Unique Device Identification Database. Read More
CDRH Office of Compliance Director Steve Silverman told senior staff that he was leaving the FDA last month to pursue opportunities outside the government. His last day at the agency was Jan. 16, according to an internal memo provided to GMP. Read More
Ensuring that product components and supplies are of top quality and delivered on time is key to running a successful business, and supplier qualification surveys need to be sufficiently broad to ensure a good result, an industry expert says.
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