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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
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
MDR reports often “describe the same problem, creating a process where the FDA conducts duplicate reviews of common malfunctions,” said CDRH Director Jeff Shuren. Read More
Facilities in India, Lithuania and Texas drew warnings from the FDA for a variety of noncompliances, including inadequate device history records. Read More
FDA medical device adverse event codes will soon be harmonized with IMDRF terminology — a move that is expected to benefit not just regulatory bodies, but devicemakers and consumers. Read More
The firm’s device history records for its recalled lots did not include the final quantity of products reviewed, approved and released for distribution. Read More
An FDA-convened panel previously found the devices are associated with various complications, such as damage to blood vessels, nerves, and connective tissue. Read More