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Recent FDA guidance on distributing scientific publications that cover off-label uses is out of touch with today’s data-driven economy and should be modified to embrace digital communication platforms, a Washington, D.C. think tank says. Read More
CDRH is steadily chipping away at PMA and 510(k) review times, but the improvements are not enough to make the US competitive with the EU, which sets a far lower bar for approving new devices. Read More
As EU notified bodies begin conducting the unannounced audits required by the European Commission, devicemakers need to make sure they have at least two employees who are prepared to handle an audit. Read More
Devicemakers seeking authorization to market Class II products in Canada will need to submit labeling with their licensing applications, under draft guidance released Oct. 20. Read More
Manufacturers of low- and moderate-risk devices will soon be able to register their products in Australia based on CE mark certificates issued by European notified bodies, under a government action plan introduced this month. Read More
The Centers for Medicare & Medicaid Services is willing to pay for Myriad Genetics’ Prolaris prostate cancer test via a local coverage determination proposed by a South Carolina Medicare contractor. Read More
The FDA issued a final rule Wednesday placing nucleic acid-based IVDs for the detection of Mycobacterium tuberculosis complex in Class II with special controls. The rule also covers use of the tests to detect genetic mutations associated with MTB complex antibiotic resistance in respiratory specimens. Read More
The U.S. Food and Drug Administration’s authority to reconsider and rescind earlier classification decisions could be severely limited following a recent federal court ruling. Read More