Critical subcontractors and crucial suppliers will be subject to unannounced audits by notified bodies under the revised European device regulations. Richard DeRisio of TÜV Süd provides more details in this presentation.
The creation of the Office of Combination Products more than a decade ago may have been a big step forward, but frustrations surrounding policy-making and coordination between CDRH, CDER and CBER remain.
Take a quick trip to the FDA’s warning letter page and you’ll see the potential danger that novelty lenses pose.
This year’s work plan includes several items that will impact medical device manufacturer and suppliers.
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.
Perhaps now is the time to truly weigh patient outcomes versus the risks associated with the reprocessing of duodenoscopes.
Perhaps now is the time to truly weigh patient outcomes versus the risks associated with the reprocessing of duodenoscopes.
Do not be the organization that fails to perform the audits and attempts to correct the issue after FDA arrives.
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.
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.
There is no such thing as minimum or maximum compliance—there is just compliance.
