3d printing fda regulations

China Food and Drug Administration Issues New Draft Guidance for 3D Printed Medical Devices

Regulations make the world go ’round…especially when it comes to 3D printed medical devices. The US FDA released draft guidance in May 2016, seeking feedback and continuing to explore the…

Stryker’s Latest 3D Printed Spinal Implant Receives FDA Clearance

3D printing has played a big role in helping those with spinal conditions, and one of the most prominent companies in the 3D printed spinal implant sector has been Stryker….

Insights from the FDA on the Future of 3D Printing in Medical Markets

As additive manufacturing has made its way into the healthcare arena, the technology has opened up new possibilities in the creation of patient-specific medical products such as anatomical models and…

FDA Guidance for 3D Printing of Medical Devices and Eligible R&D Tax Credits

The exponential growth of 3D printing technology and its application across various industries has been tremendous. In the medical field specifically, 3D printing has contributed to both clinical and innovative…

FDA Commissioner Releases Statement and New Guidance on 3D Printed Medical Devices

You can’t get anywhere with 3D printed medical products and devices in the US market without the extremely important approval of the Food and Drug Administration (FDA), an agency within the…

Stryker and Omegasonics Receive Important Industry Certifications for 3D Printed Spinal Implant and Ultrasonic Cleaning Unit

In the winter of 2016, medical device manufacturing company Stryker decided to commit to 3D printing and announced the launch of a 3D printed spinal implant, as well as a planned…

FDA (510)k Clearance Awarded to 3D Printed Medical Implants from Camber Spine Technologies and Renovis Surgical Technologies

Following in the recent footsteps of SI-BONE’s iFuse-3D Implant and Cellular Titanium spinal implants by EIT, two more medical device companies have announced this week that they have received the all-important (510)k…

First 3D Printed Titanium Implant for the Sacroiliac Joint, the iFuse-3D Implant, Gets FDA Clearance

Titanium has been used to 3D print all sorts of items, like hearing aids and airplane parts, and even a Garmin cycle mount, but the metal is really making a difference in…

3D Printers Used to Manufacture Medical Parts Should Be Regulated

As a company that has been inventing and manufacturing 3D printers and materials for 15 years, our company has had a front-row seat to amazing changes in the way things…

FDA Approved: OssDsign AB Will Now Offer 3D Printed Cranial Implant Technology in US

While the impacts of 3D printing are being seen around the world and in nearly every major industry, it’s hard to imagine what could be more important than the progress…

FDA Video Introduces the Three Rs of Medical 3D Printing

It’s always exciting when 3D printing can play a role in making someone’s life better, and one of the very visible ways it does this is through the medical field,…

K2M Group Expands 3D Printed Spinal Solutions Portfolio Following FDA Clearance for CASCADIA Titanium Systems

For most, magic is in the air from the moment you unpack that 3D printer, unveiling what is usually an elegant looking machine that acts as the bearer of many things…

The FDA Releases Draft Guidance for Industry & Food & Drug Administration Staff Regarding 3D Printing

When a magical new technology comes along, capable of stunning us at nearly every turn, it’s especially thrilling to be one of the rare few to be involved from the…

3D Printing: The Stories We Didn’t Cover This Week — March 12

In this week’s 3D printing news, we see that change is in the air — as always. Shapeways has just added a new coating that will make your 3D scanned and printed selfies…

Editor’s Choice: 15 of the Coolest 3D Printing Stories of 2015

2015 has been quite a year. Personally, I’ve loved it; I got married, bought a house, hit a milestone birthday, and became editor-in-chief of this great site. I’m almost sad…

FDA to Hold Public Workshop in October to Discuss 3D Printing Regulations

The Food and Drug Administration has a responsibility of protecting the public’s health, by assuring the safety of drugs, medical devices, and food supplies. Often times people forget that their…