When a product recall occurs, typically there are complaints that can be traced back to trending issues with the specific device. During the process of assessing whether a correction or removal must take place, a company should be conducting a health hazard evaluation (HHE) to determine whether a violation has occurred. Several considerations come into…
Trading the potential health risk to a few patients versus the collective good of all patients is never acceptable. Even the experts are voicing concerns over the effectiveness of duodenoscope reprocessing.
The last decade has brought more interaction between the device industry and FDA related to conducting health hazard evaluations, but companies continue to face obstacles.
A summary of the new and revised changes in ISO 13485, the second Draft International Standard (DIS2), which is planned for release this fall.
Medtronic repeatedly fails to correct manufacturing violations related to its Synchromed II Implantable Infusion Pump Systems.
From ensuring patient safety to protecting a company’s reputation, the product recall process starts with putting together the right team of qualified individuals.
As additive manufacturing comes to the forefront as a disruptive technology, industry continues to speculate about how liability will be shared.
The agency has released a draft guidance outlining its policy for accepting data from foreign clinical studies.
If all goes as planned, patients who suffer from life threatening or irreversible debilitating conditions will have faster access to new technologies.
Industry needs to understand that they do not classify a recall, the agency classifies it, advises former FDA official Steven Niedelman.
