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3D Printing The United States Food and Drug Administration

FDA Consumer Update: The 3Rs of 3D Printing – FDA’s Role

by Reed Smith on

On December 21, 2016, the U.S. Food and Drug Administration (“FDA”) posted a Consumer Update and accompanying video on the “The 3Rs of 3D Printing: FDA’s Role,” which reconfirms its position on the importance of 3D printed...more

3D Printing of Manufactured Goods: An Updated Analysis

by Reed Smith on

(NEW YORK) December 15, 2016 – Reed Smith LLP today released “3D Printing of Manufactured Goods: An Updated Analysis,” a comprehensive new white paper that provides in-house counsel and industry leaders with an in-depth look...more

Product Liability Update: October 2016

by Foley Hoag LLP on

Massachusetts Federal Court Dismisses Putative Class Action Because Defendant’s Unconditional Checks for Named Plaintiff’s Maximum Damages, Even Though Uncashed, Mooted Suit - In Demmler v. ACH Food Companies, Civil No....more

3D Printing: Health Care Miracle, Product Liability Nightmare, or Both? Insights from Nutter’s David Ferrera and Robyn Maguire

David Ferrera, partner in Nutter’s Litigation Department and chair of the firm’s Product Liability and Toxic Tort Litigation practice group, and Robyn Maguire, partner in Nutter’s Litigation Department and a member of the...more

The Promise And Pitfalls Of 3D Printing

by 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

The Future of Medical Device Manufacturing Is Here: FDA Issues Draft Guidance on Technical Considerations for 3D Printing

by 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

3D Printing Quarterly Report - Q2 2016

by 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

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

by 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

FDA Issues “Leapfrog” Draft Guidance for 3D Printing of Medical Devices

by 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

FDA Releases Draft Guidance for 3D Printed Medical Devices

On May 10, 2016, FDA released its first draft guidance for medical device manufacturers who are using additive manufacturing (AM), commonly referred to as 3D printing. The draft guidance, entitled “Technical Considerations...more

Guest Post – Highlights of FDA Draft Guidance on 3D Printing

by Reed Smith on

Another guest post today, this one by Reed Smith’s Matt Jacobson on the draft guidance document released earlier this week by the FDA. With the 3D printing of medical devices at the forefront of the burgeoning additive...more

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

by Faegre Baker Daniels 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

FDA Issues Draft Guidance for 3D Printed Medical Devices

The U.S. Food and Drug Administration (FDA) issued draft guidance for additive manufactured medical devices, more commonly known as 3D printed medical devices, on May 10, 2016. The draft guidance document, available here, is...more

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

by 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

3D Printing and the Renaissance of Local Economies

by 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

Navigating the Regulatory Issues of 3D Printing

by Reed Smith on

The increasing popularity of 3D printing is changing the future of health care far more dramatically than we would have ever imagined. Although we have blogged about 3D printing, and the Reed Smith white paper, “3D Printing...more

Extending the Patentable Life of 3D Printers: A Lesson From the Pharmaceutical Industry

Modern innovation typically occurs one step-improvement at a time. Some clients initially question whether their new application of an existing technology is patentable. Usually, the answer is ‘yes.’ Under U.S. law (and most...more

Five of the Top Drug & Device Developments in 2015

by Faegre Baker Daniels on

As 2015 winds down, we reflected on some of the year’s most significant legal developments for drug and device manufacturers. In our opinion, the bench got it right (for the most part) this year. Here is a brief recap and...more

3D-Printed Prescription Drugs a Huge Stride Forward for Personalized Medicine

by Wilson Elser on

Advances in 3D printing (3DP) technology have paved the way for pharmaceutical companies to print prescription drugs. Aprecia Pharmaceuticals recently announced that the FDA has granted it approval to manufacture Spritam®...more

3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles

by Reed Smith on

This white paper – 3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles – explores the legal ramifications and risks of the rapidly increasing use of 3D printing of medical devices. 3D...more

A Couple of Law Review Articles We Actually Like

by Reed Smith on

The last couple of times we’ve commented on new law review articles, we haven’t liked what we’ve seen very much. We’re gluttons for punishment, however, and this time we were rewarded. We found a couple of recent law review...more

Unfortunately Disappointing 3D Printing Law Review Article

by Reed Smith on

We’ve blogged before about the interesting product liability issues created by 3D printing/additive manufacturing, in particular the novel separation that these techniques create (at least potentially) between “manufacturing”...more

Some Ideas About 3D Printing

by Reed Smith on

The other day we read a thoughtful Bloomberg piece on 3D printing in the medical device context by a trio of Alston & Bird litigators. We’ve given you the link, but it might be behind a paywall. The article indicates...more

3D Printing's Main Legal Battles Will Be Over Intellectual Property [A Legal Perspective]

by JD Supra Perspectives on

According to a recent Business Insider story, the future of 3D printing is now. If recent news headlines are anything to go by, BI is onto something: from saving the life of a child with a custom-made airway tube to creating...more

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