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

The UK’s cost-benefit watchdog is recommending that the government pay for operations with a new device that repairs complex aneurysms and dissections of the thoracic aorta, because the technology could reduce the need for additional procedures and the associated risk of serious complications. Read More

The European Commission is launching a pilot program to help devicemakers better understand the kinds of clinical evidence health technology assessors need to make coverage decisions, in the hopes of avoiding last-minute conflicts as companies bring products to market. 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

As 2013 wound down, lawmakers in Japan pushed through drug overhaul legislation, paving the way for a distinct regulatory regime for medical devices and raising industry hopes that long-awaited device regulations won’t be far behind. Read More

Members of the Council of Europe are at odds over whether to allow reprocessing of single-use devices, and the disagreement could upend efforts to pass device reform legislation before EU elections in May. Read More

The FDA has issued final orders downclassifying external counterpulsating (ECP) devices, intra-aortic balloon and control system (IABP) devices and temporary mandibular condyle prostheses for certain indications. Read More

Devicemakers faced myriad challenges in 2013, as new rules and practices went into effect under the Affordable Care Act, FDASIA and the Physician Payment Sunshine Act. FDA offered guidance on a number of issues, including IVDs for research use only, medical device development tools and priority reviews. Globally, the year saw a steady push toward enactment of new device regulations in the EU, clampdowns on industry bribes in China and Brazil, and strict clinical trial compensation rules in India, to name just a few key developments. Here are 10 issues that kept industry buzzing this year. Use this list to review your regulatory program and prepare a successful business strategy for 2014. Read More