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With FDA already raising concerns about cybersecurity vulnerability in medical devices, CMS may be the next agency to jump in with an HHS audit planned for next year. Read More
Devicemakers need to be vigilant against possible embedded medical device software vulnerabilities as the FDA continues to develop a formal cybersecurity strategy, a security expert warns. Read More
With a comprehensive regulatory framework for devices set to take effect on Nov. 25, Japan’s Pharmaceutical and Medical Devices Agency still hasn’t published many of the implementing regulations, leaving industry to guess how best to prepare. Read More
The Center for Devices and Radiological Health is steadily chipping away at premarket approval and 510(k) review times, but not fast enough to compete with EU approval times, according to a new report. Read More
The U.S. Food and Drug Administration took another step toward regulating laboratory-developed tests, with the Oct. 3 publication of draft guidance on a proposed regulatory framework and another guidance on adverse event reporting. Read More
The U.S. Food and Drug Administration has reversed a controversial position and won’t require devicemakers to submit formal reports when they make safety enhancements to their products. Read More
Risk concerns are paramount in regulating software as a medical device, a harmonized document by the International Medical Device Regulators Forum maintains. Read More
The U.S. Food and Drug Administration last month issued final guidance outlining the steps manufacturers of medical device software must take spurn cybersecurity threats. Read More
With a comprehensive regulatory framework for devices set to take effect on Nov. 25, Japan’s Pharmaceutical and Medical Devices Agency still hasn’t published many of the implementing regulations, raising concerns that companies won’t be prepared to market their products in the country. Read More
Devicemakers are breathing a collective sigh of relief following the Indian government’s decision to let companies affix labels with India-specific information on their products after they enter the country. Read More
Manufacturers of low- and moderate-risk devices will soon be able to register their products in Australia based on conformity certificates issued by European notified bodies, under a government action plan unveiled Oct. 14. Read More
Devicemakers seeking authorization to market Class II products in Canada will have to submit labeling with their licensing applications, under draft guidance released Oct. 20. Read More