Advanced Biomedical Technology Inc., the first company in Taiwan, receives the FDA-announced Device Master File registering for biodegradable 3D-printing materials.
Advanced Biomedical Technology Inc. receives Device Master File (MAF) acknowledgment letter from FDA of the MeDFila® PCL-Ceramic 3D printing filament.
Advanced Biomedical Technology Inc. has successfully submitted a Device Master File to the Center for Devices and Radiological Health (CDRH) at the FDA for MeDFila®, their additive manufacturing (AM) PCL-Ceramic printing filament and received an Acknowledgment letter from the FDA confirming submission filing. For the medical device manufacturer, this MAF is now available for reference and review at the FDA.
“This MAF brings the MeDFila® another step closer to becoming the material of choice for medical 3D printing application and custom personal implant,” said Dr. Bruce Chen, CEO. “We will continue to deliver different composite material for medical 3D printing, which is a huge and growing market.”
Advanced Biomedical Technology Inc. shall provide MAF authorization letter on customer requests for their FDA’s review in the context of their product registration.
MeDFila® PCL series MAF status:
MeDFila® PCL-Ceramic (70%:30%) ; MAF Ready
Under FDA review process, MAF coming soon.
MeDFila® PCL ; MAF soon
MeDFila® PCL-Ceramic (50%:50%) ; MAF soon
MeDFila® PCL-Ceramic (60%:40%) ; MAF soon
For more information about MeDFila®
Please contact us for further information.