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The World Health Organization has published a model regulatory guidance for medical devices and IVDs intended to support developing nations that have yet to develop regulations covering medical devices. Read More
The European Commission has published an updated version of harmonized standards that devicemakers and diagnostics makers can reference to ensure their products comply with relevant EU legislation. Read More
Australia’s TGA is cautioning healthcare providers that Zimmer’s Trabecular metal knee implant may contain non-sterile implant components that could result in post-operative infection. Read More
C-PAP devicemaker Somnowell landed a May 12 warning letter for numerous quality system violations, including failure to establish procedures for quality audits and management reviews. Read More
The FDA is changing the way it categorizes investigational devices in an effort to help the Centers for Medicare & Medicaid Services make coverage determinations. Read More
The FDA approved its first blood-based genetic test to detect epidermal growth factor receptor gene mutations in non-small cell lung cancer patients. Read More
Members of the medtech industry concerned that EU device regulations expected this summer will conflict with aspects of the new version of ISO 13485 can rest easy, one expert says. Read More
Inspections conducted by France’s ANSM of makers of implantable defibrillation leads found qualification and validation processes were the largest compliance problems. Read More