What is Medical 3D Printing Technology?
Medical 3D printing, a concept where anyone could print parts of the body, used to be a concept out of science fiction literature and movies. However, since the 2000’s when medical 3D printing was developed, this medical technology has the potential to revolutionize the healthcare industry by allowing the production of customized medical devices and implants. This medical technology is regulated by the Food and Drug Administration (FDA) in the United States. The FDA does not regulate 3D medical printers themselves, but it 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.
What is the use of Medical 3D Printing?
Surgeons can produce customized implants using medical 3D printing, which can be used to strengthen or replace lost bones and joints. For example, the design of orthopaedic implants has improved due to the ability of 3D printers to create complex structures with better bone-binding surfaces and more durable materials.
Devices made using 3D medical printing are classified into one of three regulatory categories: Class I, Class II, and Class III, based on their level of risk. FDA also maintains an exemption for custom devices and has the option to issue emergency use authorizations for certain 3D-printed devices. The agency has released guidance on the type of information that should be included for 3D-printed device application submissions, but specific guidance for 3D printing in the drug or biologic domains is still lacking.
For medical 3D printing that occurs outside the scope of FDA regulation, little formal oversight exists. State medical boards may be able to exert some oversight, and some medical professional organizations have released guidelines for utilizing 3D printing at the point of care. However, these guidelines do not have the force of regulation and execution. 3D medical printing presents unique opportunities for biomedical research and medical product development, but it also poses new risks and oversight challenges. As the technology advances and becomes more widespread, regulatory oversight must adapt to ensure that the benefits of this technology outweigh the potential risks.
Regulation of Medical 3D Printing by the FDA
The FDA regulates medical products made via 3D medical printing under the authority of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee and Modernization Act (MDUFA) and the 21st Century Cures Act (Cures Act).
Devices made using 3D medical printing are classified into one of three regulatory categories: Class I, Class II, and Class III, based on their level of risk. Class I devices are the least risky and include items such as surgical instruments and handpieces. Class II devices are slightly more risky and include items like blood pressure monitors and oxygen masks. Class III devices are the most risky and include items like implantable devices and life-sustaining devices.
The FDA has issued several guidance documents to help navigate the regulatory process for 3D-printed medical devices. These include the ‘Guidance for the Content and Format of Premarket Submissions for 3D-Printed Medical Devices,’ which provides regulatory guidance on the information that should be included in application submissions for 3D-printed devices. There are also ‘Recommendations for 3D Printing in the Development and Manufacturing of Medical Device Products,’ which guide the design and manufacturing of 3D-printed medical devices. Lastly, there is the ‘Technical Considerations for the Development and Evaluation of 3D-Printed Medical Devices,’ which guides the technical aspects of 3D-printed medical devices.
Regardless of such extensive regulatory medical guidelines, some challenges still emerge when trying to regulate medical 3D-printed technology.
Challenges in Regulating Medical 3D Printing
Medical 3D printing presents unique challenges for regulatory oversight of medical technology. Some of these challenges include:
Lack of Formal Oversight
One of the biggest challenges in regulating medical 3D printing is the lack of formal oversight. While the FDA regulates medical technology and products made via 3D printing, there are many instances where 3D printing occurs outside the scope of FDA regulation. For example, 3D printing may be used in research settings or in point-of-care settings where the devices are not intended for commercial distribution. In these cases, there is little formal oversight, and state medical boards may be the only entities with the authority to regulate the use of 3D printing in medical settings. However, state medical boards may not have the resources or expertise to provide effective oversight, and there is a risk that unregulated 3D printing could lead to patient harm
Speed of Technology Advancements
Another challenge in regulating medical 3D printing is the rapid pace of advancements in 3D printing technology. This makes it difficult for regulators to keep up with the latest developments and to develop up-to-date regulations and guidance documents. For example, new materials and printing techniques may be developed that pose unique risks to patients, and regulators may not have the expertise or resources to evaluate these risks promptly. This can lead to delays in the regulatory approval process and challenges in ensuring that the devices meet the required standards.
Complexity of 3D-printed devices
Medial 3D printed devices can be highly complex, which can make it difficult to assess their safety and efficacy. For example, 3D-printed implants may have complex geometries that make it difficult to evaluate their mechanical properties or to ensure that they are biocompatible. In addition, 3D-printed devices may be made from a wide range of materials, including materials that have not been previously used in medical devices. This can make it difficult to assess the risks associated with these materials and to develop appropriate testing protocols. As a result, the regulatory approval process for 3D-printed devices may be more complex and time-consuming than for traditional medical devices.
Unique risks
Medical 3D-printed devices may present unique risks that are not present in traditional medical devices. For example, 3D-printed devices may have surface roughness or porosity that can increase the risk of infection. In addition, 3D-printed devices may have internal voids or defects that can compromise their mechanical properties or lead to failure. These risks need to be carefully assessed and addressed in the regulatory process to ensure that the devices are safe and effective for their intended use.
Will 3D Printing Become the Future of Medical Technology?
In conclusion, medical 3D printing has the potential to transform the healthcare industry by enabling the production of customized medical devices and implants. However, the regulatory landscape for 3D printing is complex and evolving, with challenges such as the lack of formal oversight, the rapid pace of technological advancements, the complexity of medical 3D-printed devices, and the unique risks associated with these devices. As the technology continues to advance, regulatory oversight must adapt to keep pace with the latest developments and ensure that the benefits of medical 3D printing are realized while minimizing the potential risks to patients. The FDA plays a crucial role in regulating medical technology made via medical 3D printing, but there are still questions related to each regulatory scenario for point-of-care manufacturing. Regulatory agencies, industry stakeholders, and healthcare professionals must work together to develop and maintain a robust regulatory framework that aligns with the evolving landscape of medical 3D printing.
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By Meharbash Kashif