Devices

FDA Draft Guidance on 3D-printed Devices

FDA has released a draft guidance on “Technical Considerations for Additive Manufactured Devices” that provides regulatory recommendations for device makers using 3-D printing in their manufacturing. The document outlines technical considerations associated with additive manufacturing (AM) processes, and includes recommendations for testing and characterization for devices that include at least one additive manufacturing fabrication step.

It is organized into two topic areas — Design and Manufacturing Considerations (Section V) and Device Testing Considerations (Section VI). The first provides technical considerations that should be addressed under Quality System requirements for your device. The other section describes the information that should be provided in 510(k), PMA, HDE and de novo submissions. “Point-of-care device manufacturing may raise additional technical considerations,” the guidance says.

Additionally, the document does not address the use or incorporation of biological, cellular, or tissue-based products in additive manufacturing. “Biological, cellular or tissue-based products manufactured using AM technology may necessitate additional regulatory and manufacturing process considerations and/or different regulatory pathways,” it says. “Therefore, all AM questions pertaining to products containing biologics, cells or tissues should be directed to the Center for Biologics Evaluation and Research (CBER).”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome