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FDA Focuses on Properties and Biocompatibility of AM Medical Devices

FDA’s current focus on additive manufacturing seeks to answer questions surrounding printed products’ mechanical properties and biocompatibility, amongst others.

Steven K. Pollack, Ph.D., Director of FDA’s Office of Science and Engineering Laboratories at the Center for Devices and Radiological Health (CDRH), outlined regulatory implications and considerations for submissions during his recent presentation at the Austen BioInnovation Institute.

FDA is regulating AM devices through the same process as traditionally manufactured devices are regulated. However, there are a few additional questions on how the manufacturing process may affect performance of the device. FDA launched a critical path project that seeks answers to the following questions:

  • How does print configuration affect mechanical properties?
  • How can 3D printed models support and enhance diagnostic imaging validation?
  • What biocompatibility tests are required and do the tests evaluate cleaning appropriately?
  • Are patient-matched devices better, and how can they be compared to standard devices?

FDA plans to release white papers, followed by a guidance document. The guidance will address technical concerns of AM medical devices. A second guidance is expected to address the question of identification of the manufacturer, as well as whether the product is manufactured by the clinician or in close collaboration with a clinician. It must be determined if this is a practice of medicine or manufacturing.

What AM printed medical devices has FDA cleared?

  • Hip cups, spinal cages, knee trays
  • Patient matched implants: orthopaedic implants, emergency and custom devices
  • Patient matched surgical guides for knee and ankle

What does FDA consider during device submission?

  • Imaging: type, accuracy and resolution, post-processing
  • Digital design: base model, algorithm to fit device to patient, design limits, features
  • Printing: print parameters, biocompatibility, finishing, cleaning

FDA also held a public workshop earlier this month on additive manufacturing, during which they discussed technical considerations of AM printed devices.

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