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Percussionaire was handed a Form 483 following an inspection of its Sandpoint, Idaho facility for not reporting a serious medical event and for not properly handling and reporting a firmware issue with some accessory devices. Read More
The FDA issued an update on Baxter Hillrom’s Sept. 30 recall of its WatchCare incontinence management system, declaring it a Class 1 recall because of the risk of serious injury or death. Read More
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