VIDEO: Use FDA-approved technologies to stay out of trouble with FDA
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WAIKOLOA, Hawaii — In this video from Orthopedics Today Hawaii 2022, Jason L. Dragoo, MD, spoke about modern-day biologics, what orthopedic surgeons should be telling patients and how stay out of trouble with the FDA.
“We have some good data to suggest that biologics can decrease pain and can decrease inflammation. But at this time, we don’t have enough information to suggest that biologics can regrow articular cartilage. So, we need to hold back on our claims that we can regrow our knees and cure our osteoarthritis,” he said.
Dragoo said that using FDA-approved technology and techniques is the best insurance to stay out of trouble with the FDA.
“The next time an [FDA representative] comes into your operating room or clinic, just ask them for the FDA approval certificate. You will always have that with you, therefore doing your best to ensure that you are not doing something that would draw attention,” he said.
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