Depending on the factory, some production employees may find it surprising that management has an important role to play in a quality system. 21 CFR 820.20 mandates that “Management with executive responsibility shall establish objectives for, and commitment to, quality”.[1] The Federal Government expects that management takes an active interest in improving the output of their company, at least in the case of medical device manufacturers.
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A Corrective and Preventative Action (CAPA) is a tool utilized in order to address an issue or a potential issue with a product or process. According to the FDA “The purpose of the corrective and preventive action subsystem is to collect information,…
Three types of Premarket Notifications can be submitted to the Food and Drug Administration (FDA) Traditional, abbreviated, and special 510Ks. The traditional 510K program is utilized to seek marketing authorization for any device. When submitting a 510K there is not a form to submit however submission requirements can be found under 21 CFR part 807.
The FDA has numerous methods of enforcing its regulations, known as enforcement actions. There are 4 total main...
All things must inevitably come to an end, including a medical device recall. Whether voluntary or FDA mandated, all...
An EUA (Emergency Use Authorization) was, until recently, rarely given. With the start of the COVID-19...
There can be a multitude of reasons why troubled projects are delayed in being abandoned or brought under...
Meeting and maintaining FDA compliance standards can be a challenge for even the most seasoned organization. Receiving...
The recent trend of U.S. Food and Drug Association citations issued to those operating in the pharmaceutical...
As we face the most challenging public health crises of our lifetimes, celebrating and thanking all those who serve...
Now more than ever, the Emergency Use Authorization (EUA) pathway for medical devices has become a popular topic. Due...
