A 510(k) is a formal announcement to the United States Food & Drug Administration (US FDA) of a company’s intent to market a medical product to the general public. Companies intending to sell products that involve application to the human body are required to give the US FDA this notification at least 90 days prior to releasing their products to the public. In order to receive ‘clearance,’ or approval to sell on the open market, from the US FDA, the notification must provide various information about the product, such as data, product uses, etc. The US FDA must then review the product and determine whether or not it is safe for human use.
In the 3D printing world, many companies must undergo this process and receive approval when producing medical implants, such as a 3D printed hip replacement, before their products can be sold. With the massive growth and development of metal 3D printers, this has become a much more common occurrence amongst 3D printing companies. For example, the ability to create titanium 3D printed implants has grown immaculately, but must be regulated and approved to ensure no toxic elements are being implanted into human bodies.
Printing such implants also require some rigorous testing to ensure there are no loose particles or powder remaining on the parts. No one would want little metal particles floating around their body. This has proved to be one of the more difficult steps, as many of the 3D printed implants contain extremely detailed geometric structures, but as 3D printing technology is continually advanced upon, will become less of a factor.
The requirement of companies to go through this certification, or ‘clearance,’ process is opening the door for more and more uses of 3D printing technology in the world. Already we have seen how 3D printing can benefit the industry in a vast array of ways, from 3D printing casts for faster bone healing to 3D printing models for pre-surgical preparations to 3D printing actual body party replacements. In the future, we can undoubtedly expect to see a constantly increasing amount of 3D printed product utilized by medical professionals, as the technology helps to change health care.