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Medical Devices › Manufacturers › 3D Printing

BakerHostetler

Considerations for 3D Printing of Medical Devices, Accessories, Components and Parts During the COVID-19 Pandemic

BakerHostetler on

The medical device industry and the Food and Drug Administration (FDA) have been experimenting with three-dimensional (3D) printing for years. Shortages of medical devices such as personal protective equipment (PPE) and...more

Shook, Hardy & Bacon L.L.P.

COVID-19: Will 3-D Printing Medical Supplies and Protective Products Expose You to Liability?

Shook, Hardy & Bacon L.L.P. on

Recently, my colleagues Colin Kelly, Caroline Gieser, Michael Polatsek, and I thought about the role that additive manufacturing (3D-printing) is playing in today’s brave new world....more

Hogan Lovells

COVID-19 and emergency inventions

Hogan Lovells on

As the spread of COVID-19 accelerates across the globe, everyone wants to find a way to tackle the pandemic, from Governments asking manufacturers to urgently make vital equipment to inventors creating innovative solutions. ...more

Morrison & Foerster LLP - Class Dismissed

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

Morrison & Foerster LLP - Class Dismissed on

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

Knobbe Martens

FDA Provides Guidance on 3D-Printed Medical Device Products

Knobbe Martens on

The U.S. Food and Drug Administration released finalized guidance regarding 3D printing in medical devices. The guidance document, which issued on December 5, 2017, is based on the FDA’s review of more than 100 devices...more

Foley & Lardner LLP

The Promise And Pitfalls Of 3D Printing

Foley & Lardner LLP on

3D printing offers great promise for innovation and manufacturing, but this tool has expanded the scope of patented products that can be easily and cheaply copied, and may make it harder to identify and prosecute infringers....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

Morgan Lewis

FDA Issues “Leapfrog” Draft Guidance for 3D Printing of Medical Devices

Morgan Lewis on

3D printing raises significant technical considerations for device manufacturers. In response to the increasing use of 3D printing in the medical device arena, on May 10, the US Food and Drug Administration (FDA or...more

Faegre Drinker Biddle & Reath LLP

FDA Draft Guidance Outlines Regulatory Requirements for 3D Printed Medical Devices

Faegre Drinker Biddle & Reath LLP on

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

Robins Kaplan LLP

3D Printing, Innovation Protection, and Manufacturing: The Big Change is Now

Robins Kaplan LLP on

Intellectual property (IP) law is undergoing a major transformation just as additive manufacturing? or 3D printing? has begun to revolutionize the manufacturing industry. The interplay between these two forces could end up...more

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