Shawn M. Schmitt
Latest From Shawn M. Schmitt
King & Spalding quality expert Eric Henry urges device makers to be inspection-ready by making sure the right people are in the right roles.
The US FDA on 7 October recognized a portion of the Oncology Knowledge Base, or OncoKB, which test makers can use as they work to complete premarket submissions. It’s the first database of somatic variants in cancer to be listed in the agency’s Public Human Genetic Variant Databases.
Thousands of procedure packs made by DeRoyal Industries Inc. are being recalled because they include a NORMOFLO Irrigation Warming Set that was the subject of a recent high-risk class I recall by manufacturer Smiths Medical because the device may leach aluminum.
In the inaugural episode of our new deep-dive podcast Speaking Of Medtech, former US FDA device center compliance chief Steve Silverman and Medtech Insight executive editor Shawn M. Schmitt discuss remote facility inspections and question whether they’re the wave of the future.
Medtronic on 5 October widened its 2019 recall of MiniMed pump models 630G and 670G because there’s a chance they can over- or under-dose patients. It also expanded an unrelated 2018 recall of remote controllers used with specific MiniMed pumps due to cybersecurity concerns.
With news of high-risk medical device recalls and troubles with COVID-19 diagnostics, product safety was of paramount concern to Medtech Insight readers in September. Also topping the most-read list were articles focused on pediatric patients, the revocation of emergency use authorizations for products to treat and diagnose COVID-19, and more.