News & Analysis as of

3D Printing Food and Drug Administration (FDA) Additive Manufacturing

Tarter Krinsky & Drogin LLP

Patenting And The New FDA Guidance On 3-D Printing Of Medical Devices

The U.S. Food and Drug Administration (FDA) recently finalized its publication on additive manufacturing (commonly referred to as 3-D printing) for medical devices. According to FDA Commissioner Scott Gottlieb, the guidance...more

Morrison & Foerster LLP - Class Dismissed

3D Printing Meets Medical Devices: FDA Weighs In On Additive Manufacturing

In December, the U.S. Food and Drug Administration (FDA) issued guidance on Technical Considerations for Additive Manufactured Medical Devices. The guidance represents FDA’s efforts to provide regulatory direction about...more

Hogan Lovells

FDA finalizes 3D printing guidance

Hogan Lovells on

On December 5, 2017, the U.S. Food and Drug Administration (FDA or the Agency) finalized its “leapfrog guidance” entitled, “Technical Considerations for Additive Manufactured Devices”. ...more

K&L Gates LLP

The Future of Medical Device Manufacturing Is Here: FDA Issues Draft Guidance on Technical Considerations for 3D Printing

K&L Gates LLP on

A few years ago, a custom-fabricated bioresorbable tracheal splint saved the life of an infant suffering from a collapsed bronchus due to severe tracheobronchomalacia. The splint was implanted around the baby’s airway,...more

Benesch

3D Printing Quarterly Report - Q2 2016

Benesch on

3D printer shipments in U.S. jump 20% in 2015: IDC - International Data Corp (IDC) research found 3D printer shipments in the U.S. grew by almost 20% in 2015 compared to 2014. Looking ahead, 3D printer shipments in the...more

Benesch

FDA’S Draft Guidelines for 3D Printing of Medical Devices

Benesch on

On May 10, 2016, the FDA issued a document entitled Technical Considerations for Additive Manufacturing Devices. The document consists of 25 pages of “draft” guidelines that provide the FDA’s “initial thinking on...more

Faegre Drinker Biddle & Reath LLP

FDA Draft Guidance Outlines Regulatory Requirements for 3D Printed Medical Devices

On May 10, 2016, FDA released a much-anticipated draft guidance (the “Guidance”) concerning medical devices that incorporate additive manufacturing (AM) technologies, a category which includes 3D printed devices. AM...more

Benesch

Benesch’s 2nd Annual 3D Printing Seminar (A Summary Repeat)

Benesch on

Several hundred business leaders, engineers, attorneys and academics gathered last week for an annual symposium on 3D Printing hosted by Benesch, Friedlander, Coplan & Aronoff. The ability to form physical objects from...more

Benesch

3D Printing and the Renaissance of Local Economies

Benesch on

The rise of 3D printing holds tremendous potential to impact the economy from the local to the national level. Although it is still an estimated five to 10 years away from mainstream consumer adoption, we are already seeing...more

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