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.

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.

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.

The US FDA has been furiously releasing a boatload of updated, draft and new guidance documents over the past month. On this week’s podcast, we discuss three of them, related to clinical decision support (CDS) software, Humanitarian Use Devices (HUD) and Humanitarian Device Exemption (HDE).