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AdvaMed called for Health Canada to revise and clarify its draft guidance on licensing requirements for implantable devices made through 3D printing. Read More
As the partial government shutdown entered a record-setting fourth week, the FDA expanded high-risk inspection activities by bringing back more unpaid staff. Read More
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The FDA issued draft guidance to clarify radiation control regulations for diagnostic x-ray systems and their major components, including recordkeeping, reporting, manufacturing, importing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