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Companies need to know how to access their archives — day or night — when using a third party for document storage and preparing for an FDA inspection, an FDA inspections expert advised at the WCG FDAnews Annual FDA Inspections Summit in Washington, D.C., Nov. 16-18. Read More
The FDA has released a cybersecurity action plan that aims to incrementally take the agency to a “zero trust” environment meant to strengthen the FDA’s ability to protect sensitive information and decrease overall security risks to the agency. Read More
A comprehensive readiness plan for an FDA inspection includes thorough knowledge of your document archiving and transfer procedures, according to an FDA inspections expert speaking at the WCG FDAnews Annual FDA Inspections Summit in Washington, D.C., Nov. 16-18. Read More
A retrospective analysis of Masimo SET pulse oximetry readings in healthy Black and White volunteers showed no clinically significant bias due to skin pigmentation, the company said, citing a study reported in the Journal of Clinical Monitoring and Computing. Read More
Philips Respironics has informed the FDA of two new potential issues with its reworked Trilogy ventilators that were part of a June 2021 recall. Read More
Devicemakers need to be prepared to comment as the FDA rolls out guidance related to the incorporation of ISO 13485:2016 into the FDA’s proposed Quality Management System Regulation (QMSR), said a former senior agency official at the WCG FDAnews 17th Annual FDA Inspections Summit in Washington, D.C. Read More
The FDA posted a series of frequently asked questions (FAQ) Thursday about the use “legacy” identification numbers for medical devices as the agency shifts to the Unique Device Identification (UDI) system. Read More
Cybersecurity doesn’t just apply to the products you are building today, it applies to legacy products still in use many years after installation — and devicemakers need to install post marketing updates that either bring these older devices up to today’s standards, or make them obsolete, advised one device security expert at the WCG-FDAnews Annual Inspections Summit in Washington, D.C., on Thursday. Read More