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Sponsors of medical devices supplied in Australia would be required to ensure their devices carry UDIs and that relevant information be entered into the Australian UDI database. Read More
The FDA issued draft guidance to clarify radiation control regulations for diagnostic x-ray systems and their major components, including recordkeeping, reporting, manufacturing, importing and installation requirements for “electronic products.” Read More
Seven months after issuing a Form 483 to MiBo Medical Group following an inspection of its Dallas, Texas facility, the FDA warned the devicemaker that it had not fully addressed the problems with design control procedures, CAPA procedures or complaints. Read More
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
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