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Regulations Need to Evolve with Additive Manufacturing in Healthcare

By SME Media Staff

SME had a chance to interview Liz Richardson, who directs the Pew Charitable Trusts’ health care products project. Pew is a global, non-partisan, non-governmental organization dedicated to serving the public good. Richardson’s project conducts policy research and advocacy to reduce safety risks associated with medical and consumer products regulated by the U. S. Food and Drug Administration (FDA).

Liz Richardson, director of the Pew Charitable Trusts’ health care products project.

Ms. Richardson recently published some insights into how the FDA is approaching the emerging field of additive manufacturing in healthcare.

SME: Why is understanding how the FDA is going to approach this field so important?

Liz Richardson: About one out of five dollars spent on a consumer product in the U.S. goes toward something that is regulated by the FDA. Its impact is huge, particularly in the field of medical technology. The FDA is now looking at additive manufacturing, or 3D printing, as a new technology with great promise for patients. However, every medical product comes with potential risks, including those made using a 3D printer. These risks need to be understood and mitigated through sound policy and regulation.

SME: How do you think the FDA will approach this task?

Richardson: The FDA has said that it views 3D printing as being not unlike other manufacturing techniques. To FDA staff, it is just another technology and not particularly exotic. Part of the reason for this view is that the FDA does not regulate 3D printers themselves. Instead, FDA regulates the medical products made via 3D printing.

The type of regulatory review required depends on the kind of product being made, the intended use of the product, and the potential risks posed to patients. Devices, such as orthopedic implants or dental work, are the most common type of product made using 3D printing in 2020. These are regulated by FDA’s Center for Devices and Radiological Health and are classified into one of three regulatory categories, or classes.

These classes are based on their level of risk and the regulatory controls necessary to provide a reasonable assurance of safety and effectiveness. Class I devices are low risk and include products such as bandages and handheld surgical instruments. Class II devices are considered moderate risk and include items such as infusion pumps, while Class III devices, which are considered high risk, include products that are life-supporting or life-sustaining, substantially important in preventing impairment of human health, or present an unreasonable risk of illness or injury. A pacemaker is an example of a Class III device. To date, most FDA-reviewed products developed via 3D printing have been medical devices such as orthopedic implants, with more than 100 reviewed.

SME: Can you explain a little more about the importance of viewing regulations through a Class structure?

Richardson: Regulatory scrutiny increases with each corresponding class. Most Class I and some Class II devices are exempt from undergoing FDA review prior to entering the market, known as premarket review. However, they must comply with manufacturing and quality control standards. Most Class II devices undergo what is known as a 510(k) review (named for the relevant section of the Federal Food, Drug, and Cosmetic Act.) In a 510(k) review, a manufacturer demonstrates that its device is “substantially equivalent” to an existing device on the market, reducing the need for extensive clinical research. Class III devices must submit a full application for premarket approval that includes data from clinical trials. The FDA then determines whether sufficient scientific evidence exists to demonstrate that the new device is safe and effective for its intended use.

SME: What about manufacturing devices outside of factories, in clinics or hospitals?

Richardson: That is often referred to as distributed-point of care (POC). One of the unique advantages of 3D printing is tailoring a device for a specific patient, in the hospital or clinic where the patient is seeing a doctor. With 3D printing, for example, an orthopedic implant can be built from scans of a person’s knee. The surgeon would not need to choose from a limited set of replacements. However, the FDA has not yet issued formal guidance on how it will regulate POC manufacturing, which is a potentially significant gap given the rapid uptake of 3D printers by hospitals over the past few years.

The number of U.S. hospitals with a centralized 3D printing facility has grown rapidly, from just three in 2010 to more than 100 by 2019. As 3D printing evolves, this POC model may become even more widespread, which poses a challenge for regulators, particularly in cases where an organization or individual is making complex Class II or Class III devices with limited experience meeting FDA regulations.

Particularly for highly personalized devices, it is not yet apparent how the agency should adapt its regulatory requirements—its approach to inspections, or to review and approval, for example—to ensure that these 3D-printed products are safe and effective for their intended use. Another potential challenge relates to the fact that FDA does not directly regulate the practice of medicine, which is overseen primarily by state medical boards. Rather, the agency’s jurisdiction covers medical products. In some clinical scenarios where 3D printing might be used, such as the printing of an anatomical model used for planning surgery, or perhaps one day the printing of human tissue for transplantation, the distinction between product and practice is not always easy to know.

SME: What are the critical issues for the future, as you see them?

Richardson: FDA’s Center for Devices and Radiological Health is developing a risk-based framework that includes five potential regulatory scenarios for POC 3D printing of medical devices. This will be a very important step in articulating how the agency will address these issues. However, it’s not clear when this will be published.

Questions remain related to each regulatory scenario for POC manufacturing. For example, it is unclear how the agency will define a “minimal risk” device that will not require review. Should only Class I devices be considered minimal risk or is this determination independent of classification? Is off-label use considered minimal risk? Two regulatory scenarios that the agency envisions would involve a close collaboration between a device manufacturer and a health care facility. In those scenarios, who assumes legal liability in cases where patients may be harmed? Who ensures device quality, given that a specific 3D-printed device depends on many factors that will vary from one health care facility to another? Co-locating a manufacturer within a health care facility raises questions about the distinction between the manufacturer and the facility, in addition to liability concerns. Finally, many health care facilities may be ill-prepared to meet all the regulatory requirements necessary for device manufacturers, such as quality system regulations.

At least one medical professional organization, the Radiological Society of North America (RSNA), has also released guidelines for using 3D printing at the POC, including recommendations on how to consistently and safely produce 3D-printed anatomical models generated from medical imaging, as well as criteria for the clinical appropriateness of using 3D-printed anatomical models for diagnostic use. Other professional societies may follow suit as 3D printing becomes more frequent in clinical applications. However, such guidelines do not have the force of regulation.

SME: What other challenges do you think are important?

Richardson: It will be challenging for FDA to determine how it should deploy its limited inspection and enforcement resources, especially as these technologies become more widespread and manufacturing of 3D-printed devices becomes more decentralized. Furthermore, as the technology advances and potentially enables the development of customized treatments, including drugs and biological products, FDA’s other centers will need to weigh in on 3D printing. The agency may need to define a new regulatory framework that ensures the safety and effectiveness of these individualized products.

For now, the industry will have to contend with some uncertainty surrounding how the FDA will regulate the POC model. The agency’s approach should become clearer in the next couple of years, so it will be important to track this work closely.

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