As a plastics professional, medical application were always considered to be a specialty area for injection molders and other processors. In 3D printing, medical applications are also a specialized area that requires specific knowledge of regulations, materials, and end uses. For this posting, let’s go over what a Class I device is and why this may be an area that 3D printing fits into in most cases.
Typically 3D printed parts fall into one of three areas; prototypes and models, components and end use parts. Each will be subject to different regulations.
Parts are that used as models such as pre-surgical planning, patient education tools, concept validation for manufacturing or pre marketing samples are typically used the same way a regular prototype are used and are not “in general” subject to regulation. These models are not considered a device. No patient fluids or liquids are in contact with the components and the part is strictly a concept model, fit and form validation model or a component. You can probably assume that the 3D printed part in these cases is strictly a component is not subject to reporting.
A Class I device, per the FDA, is a device where the device isn’t subject to pre-market notification or requirements versus other classes of devices that require extensive FDA approvals and testing. For Class I devices exempt from [510(k)] the submission of a [510(k)] and marketing clearance from FDA is not required but your adherences to other general controls and practices are still required. General controls such as registration and listing, labeling, and good manufacturing practices apply and have their set of guidelines per the FDA. And, there are the typically forms and fees that will have to be submitted if you are considered to be the entity of record as well as a subcontractor in some cases. For more information, you can go to:
According to the chart from the FDA site that notes the probable registration requirements for a company – most 3D printed parts that are furnished to an OEM will not be subject to reporting.
If you go to market your device that is 3D printed however, you would be considered the manufacturer and may be subject to register, list and fees. In those cases, the specifics of FDA regulations that may apply and a conservative approach with legal advice are appropriate due to liability. Aside from regulations a 3D printer with equipment may also be required to be in compliance with good manufacturing practices including quality control standards and documentation. Those standards may include the components of an ISO certification, standardized quality systems, and more, depending on the OEM.
When in doubt, ask lots of questions, set the expectation and feedback parameters, and understand what the part is going to be used as and when.