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The association pointed to the upwards 200,000 computers across more than 150 countries that were victims of the WannaCry ransomware attack earlier this year. Read More
The FDA has classified genetic health risk assessment systems as Class II with special controls, and is proposing to exempt the devices from premarket reviews. Read More
The FDA released final recommendations for manufacturers of x-ray imaging devices aimed at clarifying the premarket review process and encouraging pediatric indications. Read More
Devicemakers were mostly supportive of the Therapeutic Goods Administration’s plan to strengthen sanctions and penalties in Australia so it could respond better to repeated non-compliance. Read More
The FDA has finalized a more detailed “leapfrog guidance” on additive manufactured, or 3D-printed, medical technologies outlining some of its initial thoughts on technical considerations. Read More
The FDA released final guidance on requirements for direct marking of devices with unique device identifiers. The final document closely resembles the draft version issued in June 2015. Read More
The percentage of FDA-approved clinical trials that include patient-reported health outcomes has reached 80 percent, CDRH Director Jeff Shuren said at the FDA/CMS Summit. Read More