Regulatory Affairs

FDA Clears EarlySense Bedside Monitor

The FDA has granted 510(k) clearance for Israel devicemaker EarlySense to market an updated version of its EarlySense bedside monitoring system, the company announced Wednesday. Read More

India Offers Detailed Guidance on Registration, Import of IVDs

India’s Central Drugs Standard Control Organization has issued detailed guidance on submission requirements for the registration, reregistration and import of notified in vitro diagnostic kits and import of non-notified kits, with the aim of facilitating application reviews and easing transition to electronic submissions. Read More

AHWP Steps Up Adoption of Global Device Standards

The Asian Harmonization Working Party has released a strategic framework aimed at bringing medical device regulation of member nations in line with recommendations of the Global Harmonization Task Force, now known as the International Medical Device Regulators Forum. Read More

U.S. UDI Guidance Brings Calls for Timeline Extensions, Clarity

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

IMDRF Issues Final Guidance on UDI, Software as a Medical Device

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

NICE Recommends NHS Coverage of Novel Heart Disease Device

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

EC Pilot Looks to Speed Coverage of Promising New Technologies

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

Year in Review: Devicemakers Ride Regulatory Roller Coaster Into 2014

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