FDA guidelines for 3D printed medical devices (part I)

As the FDA is the main organ responsible for approval of 3D printed medical devices, it developed specific, technical considerations of additive manufactured devices. This includes Design and Manufacturing and Device Testing. The requirements are also measured in terms of the Quality System (QS), which a device needs to fulfill in order to be approved for the usage. When the premarket approval (PMA) is provided, the device is accepted on the medical devices market and can be delivered to the patients and medical centers directly.

Addictive manufacturing of the medical devices market is regulated by the FDA (Food and Drug Administration) and its guidance, however, it doesn’t cover all of the requirements. It is focused mainly on the technical consideration of the process. When it comes to point-of-care manufacturing when different materials, also biological, tissue and cellular-based come into consideration, the procedure is generally controlled by the Center for Biologics Evaluation and Research (CBER) instead, which is a part of FDA.

The 3D printed medical devices that include implants, dental or surgical instrument are regulated by 3 FDA organs:

The first of them regards medical devices, second biologics and third drugs. What is also considered in the FDA guidance are materials, printing and post-processing, parameters, physical or mechanical features or cleaning and sterility, As mentioned, the independence of different types of materials or other aspects, the specific department is called to be responsible for these validations and approvals. 

What is considered by the FDA in the Design and Manufacturing process validation? 

The medical devices that are being considered in this phase of the process are the class II and class III and some of the I class ones. All of them needs need to meet the requirement of the 21 CFR 820.30 Design Controls. What is controlled in the following part of the process are the parameters of each manufacturing step. These may include technologies used to produce a device, materials and other design-related features. They basically have to be adequate for Quality System (QS) requirements. These include steps regarding:

  • Overall design of the device – this would include main parameters such as size, techniques, machine specifications, dimensions or surface type. All of these need to be checked and compared in order to ensure the desirable features, compatibility and reliability
  • Patient-specific design of the device – the relevance of the patient-anatomy needs to be ensured including sizing, dimensions or scaling. Specific criteria have to be fulfilled and they can be only modified if needed by clinical staff. The individual parameters need to be pre-determined and executed in order to have a patient-specific and customized features 
  • Imaging techniques – imaging would consider the accuracy and quality of the image, resolution, relevant dimension and accurate representation of the patient’s anatomy
  • Modeling of the devices –  the specifically pre-determined features should be identified and involved in the modeling in order to create the best and accurate model in the software
  • Software considerations – this would involve the file formats or device geometrical properties, but mainly software workflow validation and the possibility of errors,  
  • Digital design of the device – after creating a digital design of the device, build volume (placement, orientation, density etc.), support materials (temporarily supporting structure materials), slicing (layer thickness) or build paths (material delivery system) stages need to be considered
  • Materials – one of the most important parts of the process. This would consider material or chemical control or layer-by-layer monitoring of the starting and incoming materials while building the cycle of the device. Also, it is important to identify whether the material used is solid, fluid or whether it’s a polymer, metal, ceramic or a mixed one. 
  • Machine parameters and environment conditions – checking the parameter would include the energy delivery system, speed, temperature and density of a laser or electron beam
  • Post-processing – taking into the consideration post-processing phase, this would involve removing of the supporting materials, surface finishing, polishing or other reductions if necessary
  • Process validation and approval – when all of the mechanical features, characteristics, dimensions, geometry, materials, and specifications are received and software is validated as well, the documentation can be created and provided in the protocol. Then the whole process is ready to be validated. All of the stages need to be clearly described, data have to be presented and all the procedures included. If needed, the reevaluation is performed. 

We hope that we provided you an in-detailed introduction about the Design and Manufacturing process, which FDA considers in their evaluation! The Device Testing Consideration would be described in the second part of the article! In the meantime, leave us to comment below the post and read our latest articles!


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