As communication and travel have become easier, companies that were once destined to serve only a small area...
Recall
A Safe Halloween During Covid-19
The pandemic has changed quite a bit about our way of life. Despite how much has changed, kids will always be...
Global Handwashing Day
Founded in 2008, “October 15 is Global Handwashing Day a global advocacy day dedicated to increasing awareness...
Surviving A Recall
Being non-compliant in even a small detail of a regulation can result in the need to perform a recall. For...
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...
Adverse Event Reports for Devices Under an EUA
Hundreds of medical devices have been placed on the US market under an Emergency Use Authorization (EUA) to aid in the...
FDA’s Guidance on Device Establishment Inspections
Last week, the FDA finalized guidance for medical device establishment inspections, which satisfies a requirement of...
Effect of Covid-19 on FDA Formal Meetings and MDUFA
FDA released a guidance document on Monday in the form of a question and answer format to help the industry understand...
Medical Device Recalls
The COVID-19 pandemic has forced some of the most drastic loosening of regulatory requirements the FDA has ever done....
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