Root Cause Analysis A Key Element Of FDA’s ‘Case For Quality’
• By Shawn M. Schmitt
CDRH is highlighting poor root cause analysis as part of its “Case for Quality,” an initiative that encourages companies to make quality assurance an organization-wide concern. Since FDA directed firms in 2009 to write FDA-483 response letters within 15 workdays after an inspection, the agency has been concerned that companies might feel compelled to fix every citation listed on the inspection form quickly without considering root causes. “What we are worried about is that this perceived need to respond in such a manner may prevent firms from taking time for a greater root cause assessment of the systemic problems that gave rise to the FDA-483 citations,” CDRH Office of Compliance Director Steven Silverman said. The Case for Quality will also examine how companies are inspected and how to make device quality data more accessible to firms.
It’s not unusual for device manufacturers to display tunnel vision after receiving an FDA-483 inspection form, focusing only on quickly fixing the noted violations and failing to dig deeper to discover root causes.
Companies “often concentrate their efforts on addressing quality system citations to the exclusion of systemic fixes,” said Steven Silverman, director...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Medtech Insight for daily insights
The US FDA has launched the Regulatory Accelerator to expedite digital health product development. This includes resources like a Resource Index for Innovators, a Medical Device Software Guidance Navigator, and best practices for early meetings.
The exemption, which President Donald Trump announced on July 17, is intended to cut the risk of critical device shortages. Stakeholders say the technology needed to cut emissions to required levels is not yet widely available.
Dexcom has recalled several models of its glucose monitoring receivers due to a speaker glitch that may suppress vital blood sugar alerts. The FDA designated the recall, which affects thousands of devices, as class I.
A recent JAMA column called for the US FDA to create an online database of medical device labeling, arguing that the move would increase transparency and help researchers, among other benefits. Medtech Insight discussed the idea with the paper’s lead author.
Steve Bates, head of the UK BioIndustry Association, has been appointed executive chair of the government’s Office for Life Sciences as the UK restructures its life sciences approach and drives health outcomes with a new NHS Long-Term Care plan.
The UK government’s response to MHRA public consultation on risk proportionate device routes to market and physical UKCA markings adds momentum to drive for modern, agile system. Another consultation in late 2025 will propose indefinite recognition of CE-marked devices in Great Britain.
