US FDA Pilot Program Speeds Off-The-Shelf Software Validation
The Computer System Validation pilot program is exploring ways for device manufacturers to save time in implementing new information technology tools that support quality systems and other operational functions. One strategy under review: letting companies rely on software manufacturers’ own validation for low-risk functions. Also: A quality assurance manager at device-maker Zoll Medical weighs in on his company's participation in the pilot.
You may also be interested in...
While a recent final guidance when a 510(k) is needed for software changes is helpful, a key industry lobbyist says it doesn't do enough to address the bigger issue of allowing FDA more discretion to let software medical device-makers update their products quickly without burdensome agency oversight.
The US agency is looking for ways to open its upcoming Voluntary Medical Device Manufacturing and Product Quality Program – designed to gauge the manufacturing maturity of device-makers – to smaller firms, officials said at a recent industry meeting. Medtronic and Edwards Lifesciences, in particular, noted that using the Capability Maturity Model Integration (CMMI) appraisal framework could allow them to save hundreds of thousands of dollars in FDA submissions and 30-day notice fees, among other expenses.
The government collected $2.68bn from settled False Claims Act cases last year, the US Department of Justice said. Another 12 device-related cases were announced in February alone.