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FDA Is Ushering In a New Era for 3D Printed Medical Products

3D Printing and the Precision Medicine Revolution 

By:  Daniel R. Matlis, President

“Once considered a futuristic technology on the distant horizon, 3D printing of medical devices, medications and human tissue is quickly becoming a promising reality,” stated FDA Commissioner Scott Gottlieb, M.D. in his announcement.

“Patients have already benefitted from 3D printed medical products through access to personalized devices and innovative drugs that have led to significant health improvements,” he added.

Today, there are more than 100 3D printed devices on the market reviewed by the FDA. These include knee replacements, cranial and facial implants.  The Agency also approved the first drug produced on a 3D printer, which is used to treat seizures and has a more porous matrix than the drug manufactured in the traditional way, enabling the drug to dissolve more rapidly in the mouth to work faster.

“This is likely just the tip of the iceberg given the exponential growth of innovative research in this field. We envision that burn patients in the near future will be treated with their own new skin cells that are 3D printed directly onto their burn wounds. Further down the road, there is the potential for this same technology to eventually be used to develop replacement organs,” said Gottlieb.

Read the full article in FDAnews Device Daily Bulletin.

Related:  On January 10, 2018, the FDA held a webinar for industry to review the “Technical Considerations for Additive Manufactured Medical Devices” guidance document and answer questions.

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