US FDA’s Quality System Inspection Technique – or QSIT – isn’t being followed to the “T” by many agency investigators, say industry experts, including two who authored the auditing approach in 1999. Sources tell Medtech Insight that QSIT, designed to ensure that investigators look at the most important compliance issues and ask pertinent questions linked to four major quality system subsystems, is routinely bypassed by investigators bent on inspecting their own way. But it’s not unreasonable for investigators to deviate from QSIT as they follow leads wherever they may go, says a former director of FDA’s Investigations Branch who left the agency in June. Meanwhile, a key player in the development of the Quality System Inspection Technique, Tim Wells, explains why he’s drafting a “new” QSIT for industry use.
Two authors of US FDA’s Quality System Inspection Technique say too many agency investigators aren’t always following the auditing approach when conducting facility inspections, often catching device manufacturers by surprise as they manage onsite FDA audits.
The claims come as one of the authors – Tim Wells – says QSIT is outdated and desperately needs a...
Children with biliary atresia (BA) exhibited neurodevelopmental deficits and increased autism traits, with earlier surgery linked to better general neurodevelopment.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
There is considerable focus at present on how far notified bodies can go in helping position their clients to have as smooth a conformity assessment passage as possible. It is a fine balancing act for all involved, but a new document sheds some useful light.
This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.
Children with biliary atresia (BA) exhibited neurodevelopmental deficits and increased autism traits, with earlier surgery linked to better general neurodevelopment.
