3D Medical Device Printing: Industry Seeks More Clarity From FDA

Regulatory News

Medical device manufacturers are looking to coax the US Food and Drug Administration (FDA) into providing more clarity on its guidance on 3D printing, according to comments released Friday.

As 3D printing, also known as additive manufacturing (AM), continues to make headway in the market (FDA has approved 85 3D printed devices as of December 2015), and more technological advances encourage more investment, device manufacturers are calling on FDA to expand its thoughts on the field and be more specific.

In May, FDA provided what’s known as "leap-frog" draft guidance to help manufacturers with the agency's initial thinking about the technical considerations for manufacturing 3D printed devices, as well as its thoughts on characterizing and validating such devices. The guidance also focused on the design, manufacturing and testing of 3D printed devices.

Comments

The Advanced Medical Technology Association (AdvaMed), a trade group, submitted three general comments to FDA (the comment period closed 8 August) on separating patient-specific devices into a companion guidance, calling for clarity on regulatory expectations for point-of-care 3D printing and enhancements to cross center collaborations at FDA.

In terms of patient-specific or patient-matched devices, AdvaMed requests that FDA clarify in the guidance which recommendations apply to such devices and the group calls for FDA to create a stand-alone guidance on such products.

“As currently structured, the Draft Guidance is confusing,” Jamie Wolszon, AdvaMed’s associate vice president of technology and regulatory affairs, wrote. “We believe that to mitigate this confusion, there is significant benefit to creating a separate, companion guidance for patient-matched devices that addresses not only AM [additive manufacturing], but also other manufacturing technologies.”

The call for such additional guidance comes as AdvaMed says 3D printing is likely to drive a surge in patient-matched products, particularly as “current manufacturing technologies (for example: computer-controlled milling machines) that create affordable, high-quality, patient-matched products are in use today.”

FDA should also clarify its current thinking on issues such as data-handling aspects of patient-specific information, privacy, use of patient data for optimization purposes, and informed consent that are not unique to additive manufacturing.

Like AdvaMed, Johnson & Johnson also noted that patient-matched device considerations are scattered throughout the current draft and “in places it is unclear whether the considerations being addressed are specific to patient-matched devices or AM in general.”

Point-of-Care Establishment

Meanwhile, in the interest of patient safety and though there will be instances where enforcement discretion is warranted, AdvaMed calls on FDA to consider adding a statement to the draft that a point-of-care establishment that installs 3D printers and uses them to routinely manufacture devices are subject to the relevant FDA requirements, including premarket review if applicable, and post-market controls such as establishing and maintaining quality systems, as well as adverse event reporting.

“Clarifying regulatory expectations for point-of-care establishments in this guidance is of paramount importance,” AdvaMed says.

Collaborations

In addition, as FDA has indicated that 3D printing represents a new chapter for pharmaceutical manufacturing, AdvaMed suggests that, in addition to moving forward with this guidance, that FDA’s Center for Devices and Radiological Health (CDRH) “take the lead to work with its counterparts within the Agency to facilitate discussions on best practices throughout the Agency. For instance, this issue may be appropriate to present to the Combination Products Policy Council. This discussion and leadership by CDRH will be especially helpful, not only to manufacturers, but FDA field compliance officers as the move to a product-type inspection program moves forward.”

Device companies Stryker, Zimmer Biomet and Smith & Nephew also said that they worked with and support AdvaMed’s comments.

Drugmaker Novartis, meanwhile, said in its comment posted last Friday that it would be helpful if the draft guidance addressed the utilization of 3D manufacturing in the following scenarios:

• Medical devices used in human factors studies both summative and formative
• Devices used for proof of concept and rapid prototyping in both significant and non-significant risk clinical studies (particularly when used in advance of conventional manufacturing processes involving tooling and assembly)
• The use of additive manufacturing for the production of components that become part of a final medical device assembly or medicinal product packaging and delivery

Comments on Technical Considerations for Additive Manufactured Devices