Quality Control & Compliance
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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.
Latest From Quality Control
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.
Officials in the US FDA's recall divisions advised manufacturers on the best ways to work with the agency during the recalls process, including keeping track of who they're speaking with, making sure all required forms are complete, and not being afraid to use eSubmit.
'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.
QSR/ISO 13485 Harmonization Update: FDA Enforcement Discretion Likely When New Rule Stands Up; Draft Reg Coming By Year's End
All signs point to the US agency exercising enforcement discretion for device-makers when it rolls out a new final rule that merges the Quality System Regulation with international standard ISO 13485. "We'll give companies time on the transition," FDA device center chief Jeff Shuren said at the MedTech Conference on 25 September. Meanwhile, an industry insider tells Medtech Insight that a draft of the regulation probably won't be out until the end of the year because of "disagreements technically on the inside" of the agency.
Officials with the US FDA discussed new challenges the information economy poses to the agency’s recalls process at a recent conference, as well as techniques manufacturers can use to better work with the agency’s recall staff.
Device-makers that are shut out of the US agency's Case for Quality Voluntary Improvement Program (CFQ VIP) because of poor compliance histories may soon be able to join an alternative initiative that would use an industry-tailored version of the Capability Maturity Model Integration (CMMI) framework to assess manufacturing maturity and quality.
In the only device-related warning letter released by the US FDA this week, the maker of Bounder wheelchairs was cited for premarket and Medical Device Reporting violations.
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