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The FDA announced draft guidance introducing an optional submission process for determining the risks or non-risks of using an investigational in vitro diagnostic in a clinical trial involving an oncology investigational drug. Read More
The FDA issued two new guidances on development of in vitro diagnostics that use next generation sequencing (NGS) technology to create individualized, genetic-based medical plans tailored to specific patients. Read More
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