An EUA (Emergency Use Authorization) was, until recently, rarely given. With the start of the COVID-19...
Enforcement Actions
Before you “Pull the Plug” on a struggling project-Call EMMA International
There can be a multitude of reasons why troubled projects are delayed in being abandoned or brought under...
Common Causes of 483 Observations
Meeting and maintaining FDA compliance standards can be a challenge for even the most seasoned organization. Receiving...
Trends In 2020 FDA Pharma Warning Letters
The recent trend of U.S. Food and Drug Association citations issued to those operating in the pharmaceutical...
Protecting Public Health During COVID-19
As we face the most challenging public health crises of our lifetimes, celebrating and thanking all those who serve...
Medical Device EUA Transition Plan
Now more than ever, the Emergency Use Authorization (EUA) pathway for medical devices has become a popular topic. Due...
Additional Devices Exempted from 510(k) Submission
The US Food and Drug Administration released a final rule to exempt additional product codes from the requirements of...
483 vs Warning Letter: What’s The Difference?
The terms “Form 483” and “warning letter” can incite dread for those that market their medical device in the US, but...
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