Shawn M. Schmitt
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Latest From Shawn M. Schmitt
A maker of in vitro diagnostics was dinged for premarket, quality systems, Medical Device Reporting and corrections & removals violations. It's just one of two device-related warning letters released by the US FDA this week.
US FDA Compliance Branch directors Gina Brackett and Melissa Michurski shed light on the agency's use of regulatory meetings. The FDA has been pulling enforcement punches in recent years, relying more on holding the face-to-face meetings than sending warning letters.
A maker of medical equipment, health-care supplies, and radiation products used for general and plastic surgery was cited for quality systems violations in the only device-related warning letter released by the US FDA this week.
Compliance Corner: FDA Investigator Sees These 4 Common Sterilization Problems When Inspecting Facilities
Phil Pontikos, who is also the US agency's national device expert, explains how device-makers can avoid running afoul of the FDA's rules and expectations for sterilization activities.
US Regulatory Roundup, July 2019: A Quality Survey, Compliance Tips, A Raccoon Infestation, Industry's 'Perverse Incentive,' And More
Handy tips from two US FDA facility investigators were of most interest to our online readers last month, but stories about the agency's Case for Quality initiative also attracted significant attention. Meanwhile, our coverage of a discovery by investigators of live raccoons and other animals at an Arkansas distributor's warehouses, and a concern by a Siemens cybersecurity expert that device-makers have "a perverse incentive" to not disclose cybersecurity vulnerabilities, was also widely read. Here are July's 10 most popular US regulation and policy stories from Medtech Insight.
Survey Finds 1/3 Of Device Firms Don't Measure The Cost Of Quality. Here's How A Case For Quality Initiative Might Help
A recent device industry survey shows that 33% of manufacturers are likely wasting money on quality efforts that are ineffective because they're not calculating the cost of quality. The survey comes under the auspices of a Case for Quality workgroup that is looking for best ways to engage leadership at device firms in quality activities. The group says it will use the survey results to inform its work as it pens a playbook of best practices for engaging leaders that will, among other things, stress the importance of knowing the cost of quality.