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U.S. and European diabetes groups are recommending that an international registry be established to gather reports on insulin pump safety, citing lax EU device regulations that leave patients at risk. 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. Read More
Patient registries are contributing significant data on the safety and effectiveness of implanted devices, and with the advent of the U.S. FDA’s unique device identification system, it is now possible to link implant characteristics to the Global UDI Database, a recent study suggests. Read More
Submissions for radiation biodosimetry medical countermeasure devices should include well-controlled analytical studies establishing device performance across the entire range of the device, the FDA says. Read More
Foreign companies seeking to market novel medical technologies in China should have an easier time, thanks to an agreement by Chinese officials to cut regulatory red tape. Read More
Companies assuming possession of a previously cleared 510(k) device would have 30 days to register the transfer of ownership on an FDA online database, under draft guidance released late last month. Read More
The U.S. Food and Drug Administration released draft guidance late last month clarifying when human cellular and tissue-based products may be regulated solely under section 361 of the Public Health Service Act and 21 CFR 1271 and when they are regulated as medical devices, drugs or biologics. Read More
Clinical laboratory groups plan to mount a major push against the FDA’s efforts to regulate lab-developed tests at a Jan. 8 and 9 public meeting ... Read More