Considerations for external transportation of processed medical devices
The centralization of medical device processing to one facility is becoming more prevalent. Centralizing sterile processing activities reduces expenses while concentrating expertise. However, this also introduces new concerns. When sterile processing is located within the same building where instrumentation is used, transport occurs over smooth floors in a controlled environment…
FDA has begun requiring electronic De Novo submissions for new medical devices
Editor's Note Beginning October 1, the Food and Drug Administration (FDA) is mandating that all De Novo classification requests be submitted electronically using its eSTAR system, according to a final rule and guidance issued by the agency. As detailed in the September 30 release, the shift marks a procedural change…
US launches tariff investigations into medical supplies and devices, raising stakes for healthcare supply chain
Editor's Note The US Department of Commerce has initiated national security investigations that could trigger new tariffs on a wide range of imported medical products, with potentially far-reaching effects for healthcare providers, Reuters September 24 reports. The probes, opened under Section 232 of the Trade Expansion Act of 1962, cover…
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