3D printing, commonly referred to as “additive manufacturing,” is an emerging area of technology poised to revolutionize the way commercial and consumer products are manufactured. This technology is relatively nascent, and U.S. regulatory bodies have not acted quickly to enact or modify regulations to specifically address 3D-printing technologies. Earlier this month, the U.S. Food and Drug Administration (FDA) became the first agency to speak comprehensively on its present thinking and expectations for regulation of 3D-printed products.
On December 4, 2017, the FDA issued first-of-its-kind guidance to manufacturers of 3D-printed products—in this case, medical devices.1 The FDA’s 28-page guidance offers manufacturers of 3D-printed medical devices a path to regulatory compliance. While this is likely only the beginning of FDA action regarding 3D-printing technologies, this guidance could have implications for other agencies considering regulations, and courts that may perceive this non-binding guidance to constitute the industry’s standard of care.
FDA’s technical guidance document is entitled “Technical Considerations for Additive Manufactured Medical Devices.”2 The FDA describes the guidance as being “broadly organized into two topic areas: Design and Manufacturing Considerations . . . and Device Testing Considerations.” Thus it speaks both to quality requirements, and is intended to clarify the pathway additive manufacturers must follow in seeking FDA approval to sell 3D-printed medical devices (but does not apply to biological, cellular or tissue-based products). The guidance is neither binding nor likely to be static. It outlines the Agency’s current thinking on approaches to additive manufacturing, including on such topics as general and patient-matched device design, product testing, and current good manufacturing processes.
In a statement announcing the final guidance,3 FDA Commissioner Scott Gottlieb characterized the document as both a “comprehensive technical framework” and “leap-frog guidance” offering the Agency’s “initial thoughts” on medical devices created by additive manufacturing. According to Commissioner Gottlieb, the FDA’s “recommendations are likely to evolve as the technology develops in unexpected ways.” “In order to ensure the safety and effectiveness of [3D printed medical devices], [the FDA is] working to establish a regulatory framework for how [it] plan[s] to apply existing laws and regulations that govern device manufacturing to non-traditional manufacturers like medical facilities and academic institutions that create 3D-printed personalized devices for specific patients they are treating.” Although the Commissioner did not articulate the FDA’s precise agenda when it comes to 3D-printed devices, he noted that FDA engineers in the Center for Devices and Radiological Health (CRDH) have been conducting research in their own 3D printing facility to determine the effect that changes in the production and design processes can have on a device’s safety and functionality. According to the Commissioner, “[t]his research . . . helps inform us as regulators to help us understand the policy framework needed to ensure the quality and safety of 3D printed products.”
While the guidance is not technically binding, it is final. This means it expresses current Agency expectations when evaluating quality practices and premarket submissions for 3D-printed medical devices that manufacturers should follow unless they can demonstrate that an alternative approach satisfies the requirements of the applicable statutes and regulations. Highlights of the guidance document include:
- Over-Arching Principle: FDA explains that “[i]t is anticipated that [additive manufactured] devices will generally follow the same regulatory requirements as the classification and/or regulation to which a non-[additive manufactured] device of the same type is subject.”
- Quality System: Manufacturers of medical devices made in whole, or in part, by additive manufacturing should follow Quality System (QS) requirements to ensure that the devices can perform as intended. Accordingly, manufacturers should identify risks and document how they intend to mitigate those risks throughout the manufacturing process, using “all reasonably obtained knowledge about [the 3D printing] machine’s capabilities to ensure the manufacturing process outputs meet defined requirements. Quantitative knowledge of the machine’s capabilities and limitations can be gained through test builds, worst-case builds, or process validation.”
The Agency further recommends using a production flow diagram that identifies the steps involved in the manufacturing of the device to help ensure that all elements of product quality are addressed. An example of an additive manufacturing production flow chart that appears in FDA’s guidance document is reproduced below.
- 3D Printing Machines: To ensure that the product can be reliably built, FDA recommends that manufacturers compare and document the desired design of the device to the “manufacturing tolerances of the individual machine.” FDA also notes that the quality of medical products may vary when built using different additive manufacturing machines. “Therefore, knowledge of how the variability of each input parameter and processing step affects the final finished device or component is critical to ensuring part quality.”
- Material Controls: The Agency notes that materials may undergo significant chemical and/or physical changes in the manufacturing process, which could affect the integrity of the medical product. As such, manufacturers should implement appropriate material controls “[t]o ensure consistency of the incoming raw material and the final product.” In addition, manufacturers should understand and document the effects that material specification changes and material reuse have on the build process and final device.
- Post-Processing: FDA acknowledges that manufacturing steps conducted after the 3D printing process may impact the performance of the final device. It therefore recommends that additive manufacturers identify any potential detrimental effects and establish procedures to maintain device performance.
- Revalidation: FDA advises that “[c]hanges to the device, manufacturing process, or process deviations should be identified and analyzed for the potential risks they introduce.” Such changes or deviations may require the additive manufacturer to revalidate the manufacturing process. Examples of revalidation triggers include: software changes (e.g., changing or updating build preparation software); material changes (e.g., supplier, incoming material specification, reused powder, new formulation) or material handling; changes to the spacing or orientation of devices or components in the build volume; changes to the software workflow; and physically moving the printing machine.
The FDA emphasized that “[n]ot all considerations described will be applicable to every device, given the variety of [additive manufacturing] technologies, materials, and devices made with additive manufacturing.”
Will Other Agencies Follow Suit?
Although each federal agency acts independently, by issuing this guidance, FDA may have set a standard that influences other regulators. Historically, it is not uncommon for one agency’s thought leadership about a new technology or scientific advancement to influence other agencies’ thinking and action on those issues. For instance:
- In developing a summary of cybersecurity best practices in the automotive industry, the National Highway Traffic Safety Administration (NHTSA) looked to the National Institute of Standards and Technology (NIST) cybersecurity standards as a “baseline” for federal cybersecurity best practices and industry-specific security guidelines.4
- The Consumer Product Safety Commission (CPSC) has also followed the Environmental Protection Agency’s (EPA) lead on chemical risk assessments. For instance, in issuing its final rule prohibiting children’s toys and child care articles from containing specific phthalates, 16 C.F.R. part 1307, the CPSC justified the propriety of conducting a cumulative risk assessment in part by pointing to EPA’s routine use of cumulative risk assessments to assess certain chemicals.5
Implications in Medical Device Litigation?
FDA’s non-binding guidance may further influence judicial actions involving additive manufacturing, to the extent that courts treat the FDA’s guidance as evidence of the industry’s standard of care. It also would not be without precedent for courts to do so. In the food litigation context, for instance, courts have found that the FDA’s method of testing compliance also applies to plaintiffs in a private action, even though FDA’s regulations do not require private litigants to follow the same methodology. In fact, in February 2016, an MDL court dismissed claims asserted in 11 putative class action lawsuits alleging that the sugar content in Whole Foods’ store-brand yogurt was false and misleading because their evidence of a misstatement of the yogurt’s sugar content did not comply with FDA testing methodology.6
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Even though the FDA’s guidance is “final,” stakeholders can still become engaged with the FDA as it assesses how to regulate 3D-printed medical devices. FDA’s good guidance practices require that the Agency continue to accept comments at any time, and a docket has been set up to receive comments on this guidance.