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The FDA said in a new draft guidance a “least burdensome” approach should be applied throughout the medical device total product lifecycle, rather than just in premarket activities. Read More
Australia’s Therapeutic Goods Administration saw a significant increase in adverse event reports for medical devices in 2016 — logging 3,841 AERs compared with 3,359 the previous year — according to the latest data from the agency. Read More
The FDA finalized a more detailed “leapfrog guidance” on additive manufactured, or 3D-printed, medical technologies, outlining its latest thinking on technical considerations. Read More
Facilities in India, Lithuania and Texas drew warnings from the FDA for a variety of noncompliances, including inadequate validations, designs and device history records. Read More
The recent ransomware attacks in the U.S. healthcare industry have highlighted the need for increased product security for medical devices, the American Hospital Association said in a letter to the FDA. Read More
CDRH is looking to enroll a total of nine participants in its new pilot program aimed at identifying best practices for quality product manufacturing. Read More
The FDA flagged almost a dozen devicemakers for noncompliances observed during agency inspections, including inadequate medical device reporting. Read More
The FDA warned three devicemakers in Germany, The Netherlands and the U.S. for GMP and other violations, including inadequate responses to a Form 483 report. Read More
The FDA recommended the addition of a contraindication for the use of certain ultrasonic surgical aspirator devices for removing uterine fibroids. 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