Aug 23, 2016 | By Benedict

The Advanced Medical Technology Association (AdvaMed), Johnson & Johnson, and 3D printing specialist Materialise have all offered suggestions to the U.S. Food and Drug Administration (FDA) regarding its draft guidance for 3D printed medical devices. The deadline for comments was August 8.

Back in May, the FDA released its long-awaited draft guidance for 3D printed medical devices, designed to help companies produce safe items to an industry-established standard. After a quiet start to discussions, a number of important organizations ended up contributing their expertise to the guidance before the deadline for comments closed on August 8. Contributors to the open comments section included the Advanced Medical Technology Association (AdvaMed) and Johnson & Johnson, who have both called for the FDA to clarify its guidance by creating a separate set of regulations for patient-matched devices. Belgian 3D printing company Materialise also offered comments.

AdvaMed, a D.C.-based trade association consisting of medical technology companies, came up with three key points in its public comment, submitted on the deadline day of August 8. The organization firstly called on the FDA to provide a separate, stand-alone companion guidance for patient-matched devices made with 3D printing technology (or other methods such as CNC machining), to stand alongside guidance for one-size-fits-all devices. It highlighted the confusion caused by treating the two different kinds of medical device as equivalent.

“Should FDA choose to maintain a single guidance document as an alternative, clarity and detail to distinguish what applies to AM devices generally versus AM patient-matched devices is needed to avoid ongoing confusion, although we feel this will be a challenging endeavor,” wrote Jamie K. Wolszon, Associate Vice President of Technology and Regulatory Affairs at AdvaMed. “For this reason, we view this alternative to be significantly less preferable to a stand-alone guidance addressing patient-matched devices.” AdvaMed also asked the administration to state its position on the data-handling aspects of patient-specific devices created using additive manufacturing techniques.

AdvaMed also asked the FDA to lay out its thinking on point-of-care additive manufacturing services, requesting that organizations providing such services be subjected to regulations as thorough as those applicable to medical devices themselves. A third remark encouraged the enhancement of cross-center collaboration within the FDA itself; for example, between branches of the association such as the Center for Devices and Radiological Health and Center for Biologics Evaluation and Research, both of which contributed to the draft guidance.

Multinational healthcare giant Johnson & Johnson also offered its thoughts to the FDA on the 3D printed medical device draft guidance, reiterating the three key points made by AdvaMed before making some suggestions of its own. The healthcare company advocated a broader look at different kinds of additive manufacturing technologies, suggesting that the FDA include methods such as stereolithography and ink jetting in addition to powder-bed fusion printing techniques. It also advised the FDA to devise a more thorough set of regulations regarding post-processing techniques for 3D printed medical devices.

Johnson & Johnson also suggested that the Materials Controls section of the FDA guidance should stipulate that manufacturers must themselves define material-characterization specifications and material-control specifications relative to additive manufacturing: “While it is possible to characterize many different material properties, for example ‘if the material is a fluid: viscosity or viscoelasticity, pH, ionic strength and pot life,’ not all these characteristics are relevant or need to be controlled during the AM process,” wrote Philip Desjardins, Vice President of Global Regulatory Affairs Policy & Intelligence for Medical Devices at Johnson & Johnson. “For example pH and ionic strength are intrinsic material properties, but they are likely to be irrelevant to the AM process, while viscosity and pot life are key factors to good process control for AM. Routine measurement of non-relevant characteristics is an increased regulatory burden, with no tangible benefit or increase to patient safety.”

While several medical device companies had their say on the FDA’s draft guidance for 3D printed medical devices, Belgian company Materialise was the only high-profile name from the additive manufacturing world to offer comments. The Leuven-headquartered company’s contribution should come as no surprise to the industry, since Materialise CEO Fried Vancrean has been outspoken about the industry’s need for a standardized, evidence-based approach to medical 3D printing. The company’s Mimics 3D imaging software is a popular software package in the area of medical additive manufacturing.

The first key point raised by Materialise asked that the guidance recognize the role of Quality Management System standards such as those provided by ISO 13485 and the Quality System Regulations (21 CFR 820): “Materialise strongly supports using the existing mechanisms available in quality management systems to ensure the safety and effectiveness of additive manufactured medical devices,” wrote the author of the comment. “Should the FDA feel the same, Materialise requests that the relationship between the guidance and existing quality management systems be clearly defined in the final guidance.”

Front page of Materialise's comments on the draft guidance

In addition to its support of existing quality management standards, Materialise recommended that the FDA consider a risk-based approach to medical device regulations, “rather than a one-size-fits all approach in which all considerations for additive manufacturing are universally applicable to all types of additively manufactured medical devices.” The Belgian company pointed out that certain material characteristics such as interlayer bonding are more-or-less irrelevant in devices such as anatomical models, while they are extremely important in devices such as implants. In a more general comment, Materialise also asked that 3D printed devices not be subjected to higher standards than traditionally manufactured devices without good reason. Curiously, several sections of the Materialise-authored comment, including sections on post-processing and software workflow, have now been redacted.

Materialise Mimics Innovation Suite 19

Other parties to contribute comments to the FDA’s draft guidance included the Stryker Corporation, the American Orthotic & Prosthetic Association (AOPA), Novartis Pharmaceuticals, VisMed-3D, and the 510(k) Coalition.

 

 

Posted in 3D Printer Company

 

 

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