The ongoing changes in the international regulatory landscape will have a direct impact on quality management systems’ (QMS) design and implementation. Thus, this is an appropriate time to reveal a new approach to QMS thinking and analysis that will undoubtedly pave the way to the future of QMS architecture. The purpose of this webinar is to introduce some new and innovative concepts that are aimed at taking our current thinking into the future. And yes, this includes incorporating Artificial Intelligence into the design and architecture of a QMS.
When reporting an Adverse Event to the Food and Drug Administration (FDA) the best method is to utilize the FDA Adverse Event Reporting System (FAERS). FAERS is a database that contains adverse event reports, product quality complaints that led to an adverse event, and medication error reports1. All FAERS reports are easily accessible to the public.
A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.