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Regulating 3D-printed medical products.

Laura M Ricles1,2, James C Coburn3, Matthew Di Prima3

  • 1U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Tissues and Advanced Therapies, Silver Spring, MD 20993, USA.

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Summary
This summary is machine-generated.

Additive manufacturing, or 3D printing, creates objects layer by layer. This review covers U.S. regulations for 3D-printed medical devices and biologics, noting key challenges.

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Area of Science:

  • Biomedical Engineering
  • Materials Science
  • Regulatory Science

Background:

  • Additive manufacturing (AM), commonly known as 3D printing, involves layer-wise material deposition to create three-dimensional objects.
  • This technology enables the creation of medical products with novel structural and functional properties.
  • The application of AM in medicine is rapidly expanding, necessitating a clear understanding of the regulatory environment.

Purpose of the Study:

  • To delineate the regulatory landscape in the U.S. for additive manufactured medical devices and biologics.
  • To identify and discuss significant challenges and considerations associated with the regulation of these advanced medical products.
  • To provide a comprehensive overview for stakeholders navigating the regulatory pathway for 3D-printed medical innovations.

Main Methods:

  • Review of current U.S. Food and Drug Administration (FDA) guidance and regulations pertaining to medical devices and biologics.
  • Analysis of existing frameworks for evaluating novel manufacturing technologies in the medical field.
  • Identification of common challenges reported in the development and approval of 3D-printed medical products.

Main Results:

  • The U.S. regulatory framework is adapting to accommodate the unique aspects of additive manufacturing.
  • Key challenges include ensuring material safety and biocompatibility, process validation, and quality control for 3D-printed products.
  • Specific considerations arise for both 3D-printed medical devices and biologics, requiring tailored regulatory approaches.

Conclusions:

  • Additive manufacturing offers transformative potential for medical products, but regulatory hurdles must be addressed.
  • A clear and consistent regulatory pathway is crucial for fostering innovation in 3D-printed medical devices and biologics.
  • Continued collaboration between manufacturers and regulatory bodies is essential for safe and effective implementation of this technology.