Shawn M. Schmitt
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Latest From Shawn M. Schmitt
Compliance Corner: Cybersecurity Patches Aren't Recall Events – But A New 510(k) May Be Needed Over Time, Expert Says
Eric Henry with the law firm King & Spalding says that while software cybersecurity patches typically don't rise to the level of a recall, device-makers should still consider the cumulative effect of software changes on products.
Where's The Beef? Trump Executive Order On Agency Transparency A Nothingburger For FDA, Lacks Teeth To Tackle True Guidance Doc Issues, Expert Says
President Trump signed an executive order on 9 October that aims for government agency transparency around guidance documents, enforcement, inspections and other areas. But longtime industry expert Steve Niedelman of the law firm King & Spalding says the order will have virtually no impact on how the US FDA conducts business. In fact, Trump's order does nothing to tackle legitimate gripes from industry around things like guidance docs.
In the only device-related warning letter released by the US FDA this week, a manufacturer of a dental X-ray sensor and X-ray system was cited for quality systems violations. The firm also failed to notify the agency of accidental radiation occurrences.
On this week’s podcast, executive editor Shawn M. Schmitt and senior reporter Elizabeth Orr delve into recent news on medical device recalls, including tips and advice from US FDA officials, and a report about a new app that scans products and gives detailed safety and recall information.
'SoomSafety': How A Real-Life Recall Scare Led A Father To Develop A Free App That Gives Detailed Device Safety Info
When Charlie Kim and his family was taking care of their sick child Isabella inside their home, tragedy struck. A tracheostomy tube that Isabella depended on to keep her alive failed, leading to complications. Later, Kim wanted to get to the bottom of what happened and was shocked to discover that Isabella's tube had been recalled. "I was thinking, 'Wait – how did we get this if it's on recall?'" he said. That's when Kim became an advocate for patient safety by launching a company called Soom that developed a software platform to help device-makers iron the kinks out of their distribution chains. But beyond that platform, Soom developed the SoomSafety app, which allows users to scan device barcodes to get up-to-date information about the products, including whether they're subject to an ongoing recall.
US Regulatory Roundup, September 2019: QSR/ISO 13485 Mash-Up, FDA Commissioner News, New Guidance Docs, And More
The latest news on the FDA's work to harmonize its Quality System Regulation with international quality systems standard ISO 13485 captured the attention of many of our online readers last month, as did stories about an upcoming pick by President Trump to fill the agency's top spot as commissioner and a slew of new, draft and updated guidance documents. Here are September's 10 most popular US regulation and policy stories from Medtech Insight.