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The FDA has developed a draft guidance to provide the agency’s initial thinking on technical considerations specific to devices using additive manufacturing (AM) and recommendations for testing and characterization for devices that include at least one AM fabrication step.

Since the FDA is currently evaluating submissions for new 3D printed medical devices to determine safety and effectiveness, this guidance can provide manufacturers with recommendations for device design, manufacturing, and testing considerations when developing 3D printed devices. The type of premarket submission required for a device is still determined by its regulatory classification.

The guidance is broadly organized into two topic areas: Design and Manufacturing Considerations and Device Testing Considerations.The FDA seeks comments and suggestions regarding this draft document within 90 days of its May 10 publication in the Federal Register.

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