News & Analysis as of

Additive Manufacturing

FDA Guidance Offers Initial Thoughts on Technical Considerations Specific to Medical Devices Using 3D Printing

by Reed Smith on

The U.S. Food and Drug Administration (FDA) announced the availability of its guidance entitled “Technical Considerations for Additive Manufactured Medical Devices; Guidance for Industry and Food and Drug Administration...more

Food, Dietary Supplement & Cosmetics Update | Vol. IV, Issue 7

by Jones Day on

USDA Inspector General Recommends Reform of AMS Organic Program for Imports - The USDA Inspector General ("IG") reviewed the Agricultural Marketing Service's ("AMS") process used in determining whether exporting...more

Legal Issues in Additive Manufacturing Technology – Peeling Back the Layers

The Fourth Industrial Revolution is the term coined by Klaus Schwab, the founder and executive chairman of the World Economic Forum, to describe the fourth major industrial era since the first industrial revolution which took...more

Food & Beverage Litigation Update | November 2017 #2

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

Senators Urge USDA to Implement GMO Labeling - Several Democratic senators, with Sen. Bernie Sanders (I-Vt.), have sent a letter to the head of the U.S. Department of Agriculture (USDA) urging Secretary Sonny Perdue to...more

Trade & Manufacturing Alert - August 2017

by King & Spalding on

USTR Issues NAFTA Renegotiation Objectives - On July 17, 2017, U.S. Trade Representative (USTR) Robert Lighthizer released the Trump Administration’s objectives for the renegotiation of the North American Free Trade...more

Trade & Manufacturing - News of Note - August 2017

by King & Spalding on

Progress Continues Toward Additive Manufacturing Standards - In late July, the National Additive Manufacturing Innovation Institute (America Makes), the National Center for Defense Manufacturing and Machining (NCDMM), and...more

Not So Shameless Plug – New 3D Printing Materials

by Reed Smith on

This post is from the Reed Smith side of the blog only. For well over a year, now Reed Smith has been engaged in an “initiative” concerning the innovative technology, “3D printing,” also known as “additive...more

Can 3D printing technology be stolen by sound recorders?

by Thompson Coburn LLP on

The growth of 3D printing seems to know no bounds. First developed in the ’80s, 3D printing, also known as additive manufacturing, began as a method for rapidly prototyping products during research and development. But with...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

Thinking in 3D: Expiring Patents

by Benesch on

Among the next generation of 3D printing patents that will soon expire are key patents for metal-based printing processes. The patents’ expiration will almost certainly result in significant price reductions for 3D printers...more

Manufacturing as a Service

by Benesch on

CONTEXT, a market research firm, projects that the worldwide 3D printer market (including printers, materials, and ancillary services) will grow to $17.8 billion over the next five years. One reason for the rapid expansion...more

Expiring Patents; HP’s Machine; Beachwood, Ohio’s MakerGear

by Benesch on

Here is a bulletin providing further validation that the cost of 3D printing will decline. 3D printing’s key patents are expiring or soon will expire. These include patents for liquid-based, powder-based, and...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

The Government Whittles Away at Life Sciences Patents

The current U.S. Supreme Court has been noted for its hostility to patent holders in general, but the Supreme Court has been especially hostile to any sort of life sciences or software invention. The Court has attempted to...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

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

Thinking in 3D: Special Report: 2016 Consumer Electronics Show (“CES”)

by Benesch on

Benesch’s Mark Avsec attended this year’s CES show in Las Vegas, where additive manufacturing took center stage. In 2015, 3D printing stories each seemed to possess a similar headline: “Here is the first 3D-printed...more

FDA Issues Final Rule Amending Food Additive Regulations

On January 4, 2016, the U.S. Food and Drug Administration (FDA) issued a final rule amending its food additive regulations to no longer allow the use of three specific perfluoroalkyl ethyl-containing food contact substances...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

European Court of Justice Dismisses Case Regarding Confidential Treatment of Information Submitted to EFSA

by Bergeson & Campbell, P.C. on

On June 3, 2015, the General Court of the European Court of Justice issued a ruling in Luxembourg Pamol (Cyprus) Ltd. and Luxembourg Industries Ltd. (Luxembourg) vs. European Commission regarding the publication of...more

WINTER . . . I MEAN PRINTER . . . IS COMING: Game of Thrones Alleges Copyright Infringement by 3D Printer IPhone Dock

The inner twelve-year old boy in me doesn’t know which is cooler: the throne made entirely from swords for HBO’s Game of Thrones series, or the fact that 3D printer technology can now replicate that throne in my home at the...more

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