This is Compliance 360°, a podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this fifth installment, former FDA investigations branch director Ricki Chase highlights the agency's top 5 inspection observations found on FDA-483 inspection forms, including failing to have procedures for corrective and preventive action (CAPA), complaint handling, purchasing controls, process validation, and nonconforming product.
When it comes to the top flubs made by medical device manufacturers, it's all about procedures.
Specifically, firms fail to have procedures for corrective and preventive action (CAPA), complaint handling, purchasing controls, process validation, and nonconforming...
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.
