This past May, the U.S. Food and Drug Administration (FDA) issued a draft guidance regarding 3D printed medical devices and asked for comments from the medical and 3D printing industries. The draft guidance contains what the FDA considers safe and unsafe practices in the field of 3D printed medical devices.
The guidelines address issues such as materials, sanitation, how the devices will affect medical imaging, and performance and safety, among others. The regulations aim to take the guesswork out of manufacturing 3D printed medical devices by laying out how the FDA will evaluate each new device for approval. However, the FDA recognizes its limitations in understanding 3D technology, which is why the FDA asked for comments on the draft guidance.
Although the FDA anticipated significant feedback on the proposed regulations in the draft guidance, to date, it has only received three comments. Without feedback from the 3D printing and medical industries, the FDA could end up finalizing regulations that impede the advancements of lifesaving 3D printed devices. Comments will be open until August 8th, at which point the FDA will review and make changes on the draft guidance based on what little feedback they do receive.
With 3D printing at the forefront of new medical technologies, it’s surprising to see so little engagement. Healthcare giant Johnson & Johnson (J&J) just announced its partnership with a 3D printing company to produce patient-specific skull and face implants.
J&J hasn’t had the best track record with medical devices. The company is currently facing thousands of lawsuits over its Pinnacle hip implants and has already settled more than 8,000 lawsuits over its ASR hip implants.
J&J’s shortcomings illustrate the importance of thorough regulations in the medical device industry, but without more feedback, the FDA regulations could put consumers at risk.