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The FDA’s biggest challenge in protecting medical devices from cybersecurity breaches is legacy technology, says a top agency technology official. Read More
The Center for Devices and Radiologic Health (CDRH) Monday released a priorities list of draft and final guidance documents it plans to publish in 2023, including two final documents focusing on the regulatory transition out of the COVID-19 public health emergency. Read More
The FDA has granted Emergency Use Authorization (EUA) to Winnipeg, Canada-based PADM Medical’s biodegradable, plant-based face mask for use in healthcare and medical settings. Read More
The Centers for Medicare and Medicaid Services (CMS) will draft a proposed rule that would create an expedited Medicare coverage pathway for medical devices, according to a CMS op-ed piece published in JAMA Internal Medicine. Read More
Quality management in the supply chain relies on traceability of and accountability for device components and finished products anywhere in the world, according to one supply chain management authority. Read More
The FDA has announced the launch of a pilot program to give faster and more widespread access to medical devices of public health importance and strengthen the agency’s Breakthrough Devices program. Read More