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3D Printing Food and Drug Administration (FDA) Draft Guidance

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l April 2019 #3

FSMA, Prop. 65 and Supply Chain Issues Among Subjects of Food Law Conferenc - In-house and outside counsel joined representatives from the U.S. Food and Drug Administration (FDA), Department of Agriculture (USDA) and...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FDA Issues “Leapfrog” Draft Guidance for 3D Printing of Medical Devices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

Mintz - Health Care Viewpoints

FDA Releases Draft Guidance for 3D Printed Medical Devices

On May 10, 2016, FDA released its first draft guidance for medical device manufacturers who are using additive manufacturing (AM), commonly referred to as 3D printing. The draft guidance, entitled “Technical Considerations...more

Faegre Drinker Biddle & Reath LLP

FDA Draft Guidance Outlines Regulatory Requirements for 3D Printed Medical Devices

On May 10, 2016, FDA released a much-anticipated draft guidance (the “Guidance”) concerning medical devices that incorporate additive manufacturing (AM) technologies, a category which includes 3D printed devices.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

Knobbe Martens

FDA Issues Draft Guidance for 3D Printed Medical Devices

Knobbe Martens on

The U.S. Food and Drug Administration (FDA) issued draft guidance for additive manufactured medical devices, more commonly known as 3D printed medical devices, on May 10, 2016. The draft guidance document, available here, is...more

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