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This is Compliance 360°, an eight-part podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this fourth installment, former FDA investigations branch director Ricki Chase explains how your firm can better manage its quality data.
Latest From Quality Control
Members of the TEAM-NB association, which account for about half of the anticipated future force of EU medtech notified bodies, are taking a coordinated approach to applying for redesignations against the new EU Medical Device and IVD Regulations. Will they succeed?
This is Compliance 360°, an eight-part podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this third installment, former FDA investigations branch director Ricki Chase explains how your firm can build trust with agency investigators during a facility inspection.
US Sens. Johnny Isakson, R-Ga., and Michael Bennet, D-Colo., introduced legislation that calls for adopting a uniform FDA inspection process to ensure parity between audits of foreign and domestic device firms, notifying manufacturers in advance of records that will be requested during an inspection, and specifying a window of time for investigators to conduct their onsite inspections, among other requirements.
A recent Baxter settlement over moldy air filters shows a move for DOJ to enforce manufacturing quality violations as part of its False Claims Act activities.
A growing number of medtech manufacturers have expressed interest in the Medical Device Single Audit Program since MDSAP became fully operational in January. The program has also drawn interest from regulatory agencies beyond those from the five participating countries, and a policy is being framed to admit new members.
The number of device recalls fell slightly in the final quarter of 2016. While troubles with software and mislabeling continue to be a thorn in industry's side, problems with sterility popped up as the third most common reason for a product recall.
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