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May 10 — A long-awaited FDA draft guidance on using three-dimensional printing to make medical devices has good and bad news for manufacturers, an attorney told Bloomberg BNA May 10.
On May 10, the Food and Drug Administration published a notice about its draft guidance, titled Technical Considerations for Additive Manufactured Devices. Additive manufacturing is another name for three-dimensional or 3-D printing.
Attorney Amy Dow said the recommendations in the draft guidance are extensive, and manufacturers seeking clearance or approval of a 3-D printing device should be prepared to engage in rigorous design and testing to demonstrate that the use of additive manufacturing technology won't hurt the safety and performance of their devices. Dow, a Chicago-based attorney with Epstein Becker & Green P.C., told Bloomberg BNA that these burdens should decrease over time as the FDA and industry become more familiar with the use of 3-D printing technologies.
3-D printing is a fast-growing manufacturing technique that builds devices from computerized blueprints or models, by layering material only where it is needed. Using 3-D printers allows device makers to create truly anatomically matched devices or surgical guides by utilizing a patient's own medical imaging. The availability of 3-D printers is increasing, and more investment in the technology is fueling its use to make medical devices.
When final, the draft guidance document will recommend several technical aspects that device makers using 3-D printing technology should consider, such as the production process, process validation and final finished device testing.
A May 10 Federal Register notice (81 Fed. Reg. 28,876) announced the availability of the draft guidance. Comments (FDA-2016-D-1210) are due Aug. 8.
In the notice, the FDA describes the guidance document as a “draft leapfrog guidance.” Leapfrog guidances are intended to serve as a mechanism to allow the FDA to share initial thoughts regarding the content of premarket submissions for emerging technologies and new clinical applications that are likely to be of public health importance, but very early in product development.
“This leapfrog guidance represents the Agency's initial thinking, and our recommendations may change as more information becomes available,” the notice said.
Several unique aspects of 3-D printing pose challenges for the FDA in determining optimal characterization and assessment methods for the final finished device, the agency said. It cited examples such as the layer-wise fabrication process, and the relative lack of medical device history of devices manufactured using additive manufacturing techniques. In addition, using 3-D printing to manufacture devices raises validation and verification questions.
To discuss such challenges and obtain initial stakeholder input, the FDA held a public workshop on additive manufacturing in October 2014 (8 MELR 357, 5/28/14).
The draft document outlines the FDA’s expectations for addressing the technical differences between additive and traditional manufacturing processes in the design, development and testing of 3-D printed devices, Dow told Bloomberg BNA. In particular, the document is intended to assist manufacturers in applying existing quality regulations to 3-D printed devices and in collecting and submitting the data the agency requires for the clearance or approval of these products, she said.
Manufacturers new to 3-D printing are likely to benefit from the draft guidance, according to Dow. However, she added, it doesn't provide a path forward for manufacturers seeking to use 3-D printing technologies to allow printing of their devices on demand and on-site in health-care facilities where the devices will be used. “The guidance states that point-of-care manufacturing may raise additional technical considerations beyond those addressed in the guidance,” she said.
Dow also said the document says that the unique and often complex geometries permitted by 3-D printing technologies may cause problems with cleaning. These problems may not be adequately addressed at the point of care, she said. Moreover, end-user facilities may not have adequate equipment, materials or personnel to properly complete these processes, leading the FDA to recommend that only devices that are cleaned of manufacturing materials by the manufacturer be provided to end users.
The draft guidance does provide some good news for manufacturers, Dow said, referring to the confirmation in the document that except in rare instances, medical devices produced using 3-D printing technology will be subject to the same regulatory classification and testing requirements as other medical devices of the same types produced using traditional manufacturing technologies.
“This means, for example, that a device subject to pre-market notification (510(k)) requirements won’t typically be subject to more stringent pre-market approval requirements merely because it is manufactured using 3-D printing technology,” Dow told Bloomberg BNA.
A 510(k) or premarket notification clearance demonstrates that a device is substantially equivalent to another device already on the market. Clinical data typically aren't generated for a 510(k). The 510(k) process is how the FDA allows most devices on the U.S. market. The FDA says it generally reviews 510(k) submissions for class II, or moderate risk, devices.
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The draft guidance is at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM499809.pdf.
The Federal Register notice is at https://www.gpo.gov/fdsys/pkg/FR-2016-05-10/html/2016-10924.htm.
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