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Warning Letter Roundup & Recap – 28 January 2020

Executive Summary

A maker of multi-parameter patient-monitoring systems was cited for premarket and quality systems violations in the only device-related warning letter released by the US FDA this week.

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Philips Expert Urges Device Makers: Update Quality Systems To Conform To Revised Risk Standard ISO 14971

It’s time for manufacturers to begin adopting the new 2019 version of ISO 14971, the international standard for risk management widely used by industry. But firms need to do more work than just changing the date on risk-related procedures and documents to “2019,” says Jos Van Vroonhoven, a senior manager at Philips Healthcare who was intimately involved with the standard’s redo. From conducting gap assessments to creating cross-functional teams, both Van Vroonhoven and longtime industry expert Don Powers tell Medtech Insight how firms can keep their quality systems up-to-date to conform to ISO 14971:2019.

Crosswalk: ISO 14971:2007 Vs. ISO 14971:2019

Here’s a crosswalk for recently revised international risk management standard ISO 14971 and its 2007 predecessor.

Coronavirus: All FDA Inspections Of Chinese Manufacturing Facilities Come To Screeching Halt

The US agency has suspended all routine surveillance inspections in China through the end of March because of coronavirus fears, commissioner Stephen Hahn announced late on 14 February. Despite expecting medical product shortages, Hahn said the agency is being proactive: “We are not waiting for drug and device manufacturers to report shortages to us” before acting. The timing of Hahn’s statement – at 6 p.m. EST on a Friday, at the beginning of a three-day US holiday weekend – suggests he isn’t particularly excited to share the information.

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