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The updated fees range from $147,012 for registering a new Class IV device, $107,998 for a Class II/III device and $86,114 for a reprocessed single-use Class IV device. Read More
The International Medical Device Regulators Forum released new consultation documents on personalized medical devices and on optimizing standards for regulatory use following its March meeting in Shanghai. Read More
The FDA announced draft guidance introducing an optional submission process for determining the risks or non-risks of using an investigational in vitro diagnostic in a clinical trial involving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