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.
Manufacturers of partial hip, knee and shoulder implants reclassified from Class IIb to Class III may use summary technical reports as interim evidence for inclusion of their devices in the Australian Register of Therapeutic Goods, the Therapeutic Goods Administration says. Read More
Postmarket studies for devices known to affect men and women differently should be engineered to enroll more female patients, the FDA says following publication of a review of postmarket studies by CDRH scientists. Read More
Medical device companies must include all core data elements for the unique device identification database except those marked “optional,” according to the International Medical Device Regulators Forum. Data elements marked “if applicable” are mandatory in the UDID if the information appears on the product label, IMDRF adds. Read More
Even as more and more healthcare is moving into the home, manufacturers and other stakeholders remain ill-prepared to serve that patient population. That’s the conclusion of a new report by the Association for the Advancement of Medical Instrumentation. Read More
The U.S. Food and Drug Administration’s final guidance on unique device identification should allow for submission of UDI data elements within 10 days of commercializing a device, rather than requiring that they be in the Global UDI Database before market launch, AdvaMed says. The trade group warns that the higher hurdle could lead to lost sales. Read More
Devicemakers must include all of the core data elements for the Unique Device Identification Database except those marked “optional,” according to a harmonized guidance on UDI. Data elements marked “if applicable” are mandatory in the UDID if the information appears on the product label, the International Medical Device Regulators Forum says. Read More
Legislation introduced last month by Canada’s health ministry would require medical device companies to revise product labels to reflect new risk information, including updates on pediatric warnings, and conduct further tests when issues arise around vulnerable populations, such as children and the elderly. Read More
Regulatory affairs folks had little time to relax in 2013, with heated debates over the future of EU device regulations, new controls in Japan and a proposed regulatory framework in India. And that’s just the tip of things. During the year, Malaysia got busy implementing its new device law and Brazil eased the process for device registration. Members of the International Medical Device Regulators Forum cemented plans for a January launch of a single-audit pilot program, and the U.S. Food and Drug Administration finalized rules for unique device identification. Use this review to reflect on developments in 2013 and prepare a winning business strategy in 2014.Read More
The promising new hypertension treatment known as renal denervation is safe in the short to medium term, but more safety information is needed before conclusions can be drawn about its long-term benefits versus standard care in treating treatment-resistant hypertension, according to a rapid assessment by the European Network for Health Technology Assessment. Read More