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Makers of low and moderate risk devices can now use the U.S. Food and Drug Administration’s de novo pathway to gain approval without first filing for 510(k) clearance — a route the agency hopes devicemakers will take. Read More
The Brazilian government is proposing major reforms to its public-private Product Development Partnership program, doubling the allowable length of PDP agreements from five to 10 years and establishing a committee to approve the projects. Read More
Devicemakers could see their wait time to begin clinical trials cut by more than a third under a proposed regulation calling for protocols to be reviewed in their entirety, rather than in stages, as is the current practice. Read More
Sponsors of Class II and Class III medical devices in China may bypass the need for clinical trials if they can show that the product is equivalent to a product listed in the country, new guidance says. Read More
European trade groups and industry experts were cautiously optimistic regarding news that medtech oversight will move from the health directorate to industry, with some saying it will boost innovation and access to new therapies and others worried it could derail progress on regulatory reforms in the EU. Read More
The European Commission will soon launch an internal test of the International Medical Device Regulators Forum’s table of contents for medical devices and IVDs — documents designed to ease marketing authorizations process when companies file in multiple countries. Read More
The device industry is asking the FDA not to impose controls, including quality system regulations, on manufacturers of low-risk health information management software that doesn’t serve a clinical function. Read More
With 12 recalls in less than 36 months, Johnson & Johnson tops the list of the five medical devicemakers with the most Class I recalls between 2012 and the present, according to FDA data. Read More
The FDA plans to implement unique device identification requirements over several years, “and we fully expect and intend to be flexible during that time,” an agency source says. Read More
Sponsors of Class II and Class III medical devices in China may bypass the need for clinical trials if they can show that the product is equivalent to a product listed in the country, new guidance says. Read More
European trade groups and industry experts were cautiously optimistic regarding news that medtech oversight will move from the health directorate to industry, with some saying it will boost innovation and access to new therapies and others worried it could derail progress on regulatory reforms in the EU. Read More