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The agency stated that after reviewing evidence and information about the device’s use, it felt that the product “requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option.” Read More
Nearly 80 percent of the 1.6 million medical devices registered in the FDA’s Global Unique Identification Database are Class II medical devices and nearly half are implantable devices, the FDA reported. Read More
Massachusetts-based medical device manufacturer Alere and its subsidiary Alere San Diego agreed to pay the United States more than $33 million to resolve False Claims Act allegations that Alere knowingly sold unreliable point-of-care diagnostic testing devices to hospitals. Read More
The FDA issued two guidances on postmarketing safety reporting for combination products, pushing back reporting requirements for certain combination products and clarifying reporting rules for their constituent parts. Read More
The FDA is moving closer to a decision on whether to add clauses from ISO 13485:2016 to the regulatory requirements for U.S. medical devices. Read More
The standards will apply to neuroaxial applications, breathing systems, enteral applications, urethral and urinary applications and limb cuff inflation applications. Read More
Stakeholders lauded the FDA’s efforts in developing draft guidance on the use of investigational in vitro diagnostic devices in clinical trials but said the agency needs to provide more specific examples for the guidance to be useful. Read More
China’s Food and Drug Administration reported that International Medical Device Regulators Forum (IMDRF) members unanimously supported China’s proposal for a new work item on clinical evaluation of medical devices — presented during the March 20-22 IMDRF meeting in Shanghai. Read More