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My cell phone rang while I was driving home from the holidays with my family. It was my CFO calling.
“Hey Peter, how was your week?
He took a deep breath.
He said “I opened an FDA ‘Recall Notification’ letter this morning. I wanted you to know.”
The U.S. Food and Drug Administration (FDA)
Our company was excited about our newest medical device launch into the U.S. market. We and other manufacturers assumed the FDA would agree with our Class 1 medical device classification since prior releases fell under this category.
FDA investigators were still testing the new wireless capability under an “accelerated approval” classification; our wireless device was in the market.
The letter said we needed to recall all of the wireless devices we had launched into the market.
Peter was hearing from our people that the entire industry had gotten the recall notice.
The Federal government had blocked the importation of certain medical devices with wireless capabilities to protect public safety.
