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.

The US agency says its medical device program is in desperate need of an information technology upgrade, noting that its outdated IT systems, tools and approaches could leave it flat-footed when dealing with cybersecurity threats and ever-evolving medtech. That’s why the FDA is asking Congress for $18m to tackle the IT sore spot.

The US agency says it missed critical goals for evaluating product recalls and so-called Code Blue Medical Device Reports (MDRs) in fiscal year 2019 – and it’s pinning the blame squarely on a massive reorganization of its device center. This isn’t the first time the FDA has pointed to the “super office” shakeup as a disruptor.

A mere 21 quality-related warning letters were issued to device makers last year, the US agency tells Medtech Insight. It’s the third year in a row that the FDA has given out a record-low number of letters. In fact, 2019’s count of 21 represents a whopping 83% decrease from just five years ago, when 121 letters were sent to companies.

News that device giant Cardinal Health recalled millions of potentially unsafe, unsterile surgical gowns – and a message out of the US FDA for customers to “immediately discontinue” using the gowns – was of most interest to our online readers last month. Meanwhile, the FDA’s plans to hasten emergency-use approvals of coronavirus test kits and a set of 10 tips for dealing with agency investigators also garnered significant attention. Here are January’s 10 most popular US policy and regulation stories from Medtech Insight.

Exports of components and finished medical devices coming from coronavirus-stricken China will continue to flow to the US and other countries for now, but there could be trouble soon if government quarantines and international travel bans remain in place, an industry expert in Shanghai tells Medtech Insight.