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Australia’s Therapeutic Goods Administration is reviewing how it regulates software as a medical device (SaMD) and has issued guidance on its latest thinking. Read More
The FDA issued a final rule streamlining its classification procedures for medical devices and allowing for changing classifications by administrative orders rather than the rulemaking process. Read More
The FDA issued final guidance outlining what devicemakers should know about manufacturing site changes and when they should submit supplements. Read More
The firm was also called out for device history records, which lacked identification labels and labeling, and its reviews of document control procedures. Read More
The firm also didn’t document, on either return goods authorization forms or verbal complaint forms, if it evaluated the complaint to see if it should be reported to the FDA as part of medical device reporting. Read More
Working with GI Dynamics, Linhares’ focus will be on the pivotal US trial for the company’s EndoBarrier device, a treatment for type 2 diabetes and obesity. Read More