DEVICE
Coronavirus EUA Submission
Coronavirus EUA Submission– Importing N95 Masks and Hand Sanitizers As the novel COVID-19 Coronavirus continues to spread our office has been flooded with Coronavirus EUA…
FDA Device Meetings
Any meeting with the FDA on it’s White Oak campus can be intimidating, but a FDA device meeting to assess both pre-market approval and enforcement…
Three Steps to Selling FDA Approved Products on Amazon
“Is it FDA approved?” This is the most frequent question received by phone and e-mail. It’s also the most commonly asked question by Amazon. The…
Shutdown Delays Medical Device Approvals (510(k)s)
As the shutdown continues the impact continues to be felt.