FDA on Regulating the 3D Printing of Medical Devices
By MedTech Outlook | Friday, November 30, 2018
The latest trend in medical technology has been the 3D printing of medical devices. The U.S. Food and Drug Administration (FDA) has issued clarifications on regulating the non-traditional manufacturers of medical devices such as healthcare organizations or academic institutions that are into 3D printing of personalized medical devices for treating specific patients. The regulations emphasize on device design, functional testing, durability along with quality control, which the FDA opines, helps organizations innovate better.
Among the major recommendations made in the new guidance document, is a flow diagram along with a summary indicating each step deemed critical to the manufacturing process. With regard to device design, the desired features of the end product ought to be specified in the design document; to the extent possible, the size of the 3D printed device is expected to be kept minimal.
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As for the devices concerned with scanning and imaging, adequate provisions are expected to be made to ensure data security. Although the quality of the devices could vary for devices built using different additive manufacturing machines, clarity is sought on how the variation affects the quality. In the event of challenges to verifying the results completely, the process must be validated with a high degree of accuracy in accordance with the existing principles. Process deviations or changes to the manufacturing procedure could necessitate a revalidation of the entire process. With regard to testing, mechanical testing of the device is a must; the device material characterization, along with the dimensional measurements and biocompatibility of the device, are mandatory.
Doctors, physicians and radiologists have welcomed the new guidance and its emphasis on the quality, safety and reliability of devices. Further, the expert committee behind the recommendations stresses on the need for developing integrated systems within the 3D printers to enrich them with more functions. As a matter of fact, the regulations have ushered in a sense of dynamism into the entire domain of 3D printing of medical devices.