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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
“Once considered a futuristic technology on the distant horizon, 3D printing of medical devices, medications and human tissue is quickly becoming a promising reality,” stated FDA Commissioner Scott Gottlieb, M.D. in his announcement. Read More
“We are continuing to aggressively investigate this issue, including whether the use of BD tubes led to inaccurate lead test results,” CDRH’s Donald St. Pierre said. Read More