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 Staff,” which was published in the Federal Register. This guidance was previously circulated in May 2016 in a draft form and underwent a comment period, where … Continue Reading
Search Results for: 3D Printing
Upcoming Free CLE Webinar: “3D Printing: Component Parts/Raw Materials Product Liability & Health Risks”
Reed Smith is at the forefront of thought leadership surrounding 3D printing and how this revolutionary technology will impact our pharmaceutical and medical device clients, as well as universities and other leading medical centers which are incorporating this technology into patient care. Our 3D printing team has authored two white papers (available here and here) … Continue Reading
Upcoming Free CLE Webinar: “3D Printing: What Could Happen to Products Liability When Users (and Everyone Else in Between) Become Manufacturers”
The Reed Smith life sciences product liability and 3D printing teams will be hosting an upcoming CLE webinar “3D Printing: What Could Happen to Products Liability When Users (and Everyone Else in Between) Become Manufacturers” on May 8, 2017 at 12 p.m. ET. Reed Smith presenters Jim Beck and Matt Jacobson will be discussing 3D … Continue Reading
FDA Consumer Update: The 3Rs of 3D Printing – FDA’s Role
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 medical devices. The FDA sums up its role in this “innovative space” as regulate, research, and resource (i.e., … Continue Reading
Reed Smith Launches Second Edition of 3D Printing White Paper
Following up the success of its first, medical device-focused 3D printing white paper, 3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles, Reed Smith’s 3D Printing Task Force has now launched a second edition of its 3D printing publication white paper addressing 3D printed products more broadly: 3D Printing of Manufactured Goods: … Continue Reading
Please Join Us For A Reed Smith Webinar On 3D Printing – Will Regulatory Pathways and Reimbursement Change?
The Reed Smith Life Sciences Health Industry Group will be hosting an upcoming CLE webinar “Think Differently. 3D Printing – Will Regulatory Pathways and Reimbursement Change?” on July 21 , 2016 at 12:00 p.m. ET. Reed Smith presenters Gail Daubert, Celeste Letourneau and Kevin Madagan will be discussing the increasing popularity of 3D printing and … Continue Reading
FDA Publishes Draft Guidance Regarding 3D Printing Of Medical Devices
The U.S. Food and Drug Administration (FDA) has approved more than 80 medical devices that involve 3D printing and one prescription drug. It also held a public workshop to obtain information and input about 3D printing issues on October 8 and 9, 2014. FDA brought together technical 3D printing expertise from various industries and sectors … Continue Reading
Navigating the Regulatory Issues of 3D Printing
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 of Medical Devices: When a Novel Technology Meets Traditional Legal Principles” addressed regulatory issues for medical devices and … Continue Reading
ClearCorrect Ruling Keeps ITC From Policing 3D Printing and Other Digital Data Transmission
3D printing has been a common topic of discussion of the blog. We’ve written about it here and in a more in-depth review of the legal issues raised by the emergence of 3D printing in the medical device industry in our September 2015 white paper. 3D printing is in the news again thanks to the … Continue Reading
3D Printing Comes Face-to-Face with the Learned Intermediary Rule
3D Printing has been a hot subject on this blog lately. From our first 3D Printing white paper, “3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles” to our posts here, here and here. Our friends over at the Drug and Device Law blog are no stranger to the subject either. … Continue Reading
