Search Results for 3D Printing

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3D Printing: FDA Finalizes Guidance for Medical Devices By Michael Mezher - Published 04 December 2017

The US Food and Drug Administration (FDA) on Monday finalized guidance on medical device additive manufacturing, also known as 3D printing.

Categories: News, US, FDA, Manufacturing, Medical Devices

Tags: 3D Printing, Additive Manufacturing, Final Guidance

3D-Printed Anatomical Models: FDA Explains Regulatory Framework By Michael Mezher - Published 01 September 2017

The US Food and Drug Administration (FDA) on Thursday presented its case for regulating 3D-printed, patient-specific anatomical models as medical devices when they are marketed for diagnostic use at a joint meeting with the Radiological Society of North America's 3D Printing Special Interest Group.

Categories: News, US, FDA, Medical Devices

Tags: 3D Printing, Additive Manufacturing, Patient Specific Anatomical Models

FDA to Issue More Guidance on 3D Printing By Zachary Brennan - Published 21 December 2016

As manufacturers use 3D printing to create devices matched to a patient’s anatomy and devices with complex internal structures, the US Food and Drug Administration (FDA) is working with universities, researchers and industry to further understand these products and issue more guidance.

Categories: News, US, FDA, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: 3D printing, FDA regulations on 3D printing, 3D printed medical devices

3D Medical Device Printing: Industry Seeks More Clarity From FDA By Zachary Brennan - Published 15 August 2016

Medical device manufacturers are looking to coax the US Food and Drug Administration (FDA) into providing more clarity on its guidance on 3D printing, according to comments released last Friday.

Categories: News, US, FDA, Government affairs, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: 3D printing of medical devices, 3D devices, additive manufacturing

FDA Issues Long-Awaited 3D Printing Guidance for Medical Devices By Michael Mezher - Published 09 May 2016

The US Food and Drug Administration (FDA) has released a new draft guidance for medical device manufacturers working with additive manufacturing (AM), which is more commonly known as 3D printing.

Categories: News, US, FDA, Manufacturing, Medical Devices, Regulatory strategy

Tags: 3D printing, additive manufacturing

FDA Wants its Regulators to Learn More About 3D Printing, Other Device Topics By Alexander Gaffney, RAC - Published 07 August 2014

The US Food and Drug Administration (FDA) announced this week that it plans to expand a program it uses to better understand the real-world challenges of the medical device industry it regulates.

Categories: News, US, CDRH, In vitro diagnostics, Manufacturing, Medical Devices, Research and development

Tags: 3D Printing, 3-D Printing, ELP, Experiential Learning Program, General Training Program

FDA Plans Meeting to Explore Regulation, Medical Uses of 3D Printing Technology By Alexander Gaffney, RAC - Published 16 May 2014

The US Food and Drug Administration (FDA) plans to soon hold a meeting to discuss the future of regulating medical products made using 3D printing techniques, it has announced.

Categories: News, US, CDRH, Manufacturing, Medical Devices

Tags: 3D Printing, Guidance, Additive Manufacturing, Meeting