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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
As Republicans prepare to take over the Senate, hope is building among devicemakers that the political shift may signal the end of the medical device excise tax, despite a new report indicating the tax would have a minimal effect on production and employment. 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 FDA is telling Health Science Products to get certification from an outside expert, after the company purchased components from unqualified suppliers. Read More
Cook Medical is under FDA pressure to fix sweeping quality problems at its Indiana facility with the way it addressed more than 735,000 manufacturing noncomformances over a two-year period. 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and Drug Administration took another step toward regulating laboratory-developed tests, with the Oct. 3 publication of draft guidance on a proposed regulatory framework and another guidance on adverse event reporting.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