Advances in 3D printing, also called additive manufacturing, are capturing attention in the healthcare field because of their potential to improve treatment for certain medical conditions. A radiologist, for instance, might create an exact replica of a patient’s spine to help plan a surgery; a dentist could scan a broken tooth to make a crown that fits precisely into the patient’s mouth. In both instances, the doctors can use 3D printing to make products that specifically match a patient’s anatomy.
The technology is not limited to planning surgeries or producing customised dental restorations such as crowns; 3D printing has enabled the production of customized prosthetic limbs, cranial implants, or orthopedic implants such as hips and knees. At the same time, its potential to change the manufacturing of medical products—particularly high-risk devices such as implants—could affect patient safety, creating new challenges for Food and Drug Administration (FDA) oversight.
When 3D printing is used to manufacture a medical product at the point of care, oversight responsibility can become less clear. It is not yet apparent how the agency should adapt its regulatory requirements to ensure that these 3D-printed products are safe and effective for their intended use. The 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 that is used to plan surgery, or perhaps one day the printing of human tissue for transplantation, the distinction between product and practice is not always easy to discern.
This issue brief explains how medical 3D printing is used in health care, how FDA regulates the products that are made, and what regulatory questions the agency faces.
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