Regulatory Challenges Emerge for Additive Manufacturing

Regulatory Challenges Emerge for Additive Manufacturing

This piece was originally published in the August 2016 issue of electroindustry.

Megan A. Hayes, Director, Regulatory and Standards Strategy, MITA

3d printed rib cage

Additive manufacturing (AM) is another term for the synthesis of three-dimensional objects—otherwise known as 3D printing. This concept is nothing new to the U.S. Food and Drug Administration (FDA), which already has approved or cleared more than 80 medical devices and one prescription drug that are manufactured using 3D printing processes.

On May 10, 2016, the FDA issued “Technical Considerations for Additive Manufactured Devices,” a draft guidance that provides the FDA’s initial thinking on technical concerns, testing, recommendations for quality system requirements, and characterization for devices that use AM.

By issuing this guidance, the FDA is acknowledging that AM is bringing rapid change to the medical device industry and that investments in this increasingly popular technology will lead to greater use. The FDA also notes that AM has the potential to create anatomically matched medical devices and surgical implementation based on an individual patient’s medical imaging.

In general, AM presents unique regulatory challenges, which are made only more complicated by the technology’s coordination with medical imaging.

Questions abound. How should the FDA ensure that devices used for AM are properly calibrated and that the images from which they are copied provide sufficient detail for accurate reproduction? How should the agency treat the software that will translate a medical image into a file that can be applied by a 3D printer? Other IT considerations are materials, testing on patient-specific devices, tolerances, cleaning, and sterilization.

The FDA’s draft guidance does not apply to devices that involve bioprinting (which incorporates biological, cellular, or tissue-based products in the AM process), nor does it address point-of-care manufacturing (i.e., onsite printing of devices in hospitals or doctors’ offices). These two matters further complicate the regulation of AM.

As the frequency of 3D printing of medical devices grows, the FDA will need to refine its thinking on how to regulate the nascent industry.

Read the August 2016 issue of electcroindustry.

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