FDA’s 2015 Science Forum attracted more than 800 people from the scientific community. Here’s what some attendees said about the innovative research going on at the agency and why FDA can be a valuable collaborator in research aimed at transforming food safety and medical product development. If you couldn’t attend the FDA science forum, you […]
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Remote auditing – It’s not all or nothing
By Susan Gould, MBA, MS With the improvement in secure documentation sharing, many auditors are utilizing remote auditing practices to conduct audits. This saves travel time and costs and can be an efficient auditing method. However, this does not mean that all audits should be completed entirely remotely. For example, Good Manufacturing Practices (GMP) and […]
Simplified registration pathway for Class I medical devices in Russia
By Stewart Eisenhart, Emergo Group Russian medical device market regulators have eased registration and market entry requirements for low-risk Class I devices, while at the same time formalizing procedures for certain registration amendments and changes to Instructions for Use (IFU).
Emergo Podcast: Medical device distribution in Europe
By Stewart Eisenhart, Emergo Group Although the European Union has a uniform process, CE Marking, in place to allow registration and marketing of medical devices across all member states, distribution of devices requires regional expertise. In this Emergo podcast, we explain how to identify and vet European device distributors. Edgar Kasteel, Senior Manager at Emergo’s […]
Australian regulators end transition period for reclassification of joint replacement devices
By Stewart Eisenhart, Emergo Group The Australian Therapeutic Goods Administration (TGA) has officially ended the three-year transition period for manufacturers of certain joint replacement devices to apply for reclassification of their products from Class IIb to Class III.
St. Jude Medical wins MR-conditional nod from FDA for Penta chronic pain lead
St. Jude Medical (NYSE:STJ) said today that the FDA approved MR-conditional labeling for its Penta spinal cord stimulation lead for treating chronic pain. The 5-column Penta paddle lead is designed to be used with St. Jude’s Protégé MRI device, the company said, claiming it as the only such lead on the U.S. market to “allow patients to safely […]
Stryker pulls the trigger on Muka Metal acquisition
Stryker (NYSE:SYK) today confirmed an earlier report of the acquisition of Turkish hospital bed and stretcher maker Muka Metal in an all-cash transaction, but did not specify the amount. Kayseri, Turkey-based Muka began producing hospital beds in 2004, and has expanded into patient handling equipment, stretchers and hospital furniture. The company, founded in 1966, developed the 1st wireless […]
Improved graft shows hope in treating pediatric heart surgery
By Erin Horan Hypoplastic left heart syndrome (HLHS) is a rare but serious form of congenital heart disease that leaves the left pumping chamber (ventricle) of the heart severely underdeveloped. Children born with HLHS can’t pump enough oxygenated blood from their heart to the rest of their body and need surgery as soon as possible to […]
Risk mitigation: Digital apps enhance hospital’s safety
By David Altman Hospitals are among the most hazardous workplaces in the U.S. In 2011, according to the Occupational Safety and Health Administration, 253,700 accidents were reported, an average of 6.8 work-related injuries for every 100 full-time employees. Rates of injuries reported to OSHA are decreasing in all industries except for hospitals, whose rates are […]
Chinese regulators plan surprise inspections for medical device facilities
By Stewart Eisenhart, Emergo Group The China Food and Drug Administration (CFDA) will begin a new program of unannounced inspections beginning September 1, 2015 for medical device manufacturers registered to market their products in the country.
FDA China office’s Lixia Wang wins award for HHS locally-employed staff
By Mary Lou Valdez The FDA’s mission to ensure that food is safe and medical products are effective for use by U.S. consumers and patients is widely recognized. A lesser-known fact is that the U.S. Department of Health and Human Services (HHS) employs more than 1,700 locally-employed (LE) staff in 60 countries to uphold its […]