The US Food and Drug Administration (FDA) publishes the final guidelines for 3D printed medical devices, providing developers with specific steps to approve product listings. According to Modern Healthcare, Dean Carson, vice president of US operations at Anatomics, a medical device manufacturer, said the FDA issued guidelines that clearly define the procedures for manufacturing safety products to produce high quality implants that meet all standards.
Jim Shehan, FDA's regulatory practice chairman, said developers can bring their 3D printing devices to market more efficiently. The move is a continuation of the FDA's transition adoption process, which will help bring products to market faster, and manufacturers will really want to figure out what conditions to meet before applying for FDA approval.
This guide outlines the equipment design and testing required by the FDA, as well as the quality system requirements for 3D printing equipment. Several of them are particularly focused on patient matching devices. These devices are designed based on clinical information to suit a particular patient. Clinical information can come from patient measurements, clinical assessments, imaging, or a combination of these techniques.
The FDA notes that because patient anatomy can change over time, engineers need to create equipment that adapts to their changes. Carson said that as the FDA accepts this new technology, the use of patient-matched devices will increase dramatically.
However, all considerations related to 3D printing are not covered in the FDA guidelines. Advisory Board analysts said that these guidelines are not intended to regulate unconventional manufacturing facilities used by hospitals, university laboratories, etc., nor for bioprinting of human tissues and organs. Since this guide does not include it, the industry has to wait for the FDA's future regulations.
Overall, the guidelines issued by the FDA are very important to the medical industry. At the two ends of the spectrum are companies that are trying to create products that promote medical care, and the FDA that wants to ensure the safety of these products as much as possible. A guidance document like this is closing the gap between the two sides.
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