The FDA already cleared out 85 3D printed medical devices from the long list of devices piled up, and along with that, a new draft and guidance is also released for medical devices and drugs manufactured based and intended for the Additive Manufactured Devices or known as the 3D printed devices. At first, the medical doctors and professionals are looking for specific guidelines as to the safety and security of the devices and drugs administered as medical treatment or solution. Now, it was FDA who steps forward to provide the basic rules.
The FDA recognized the power and capability of the 3D printing in creating and producing new and efficient innovative medical devices. As they do, the agency created the draft to outline the considerations and guidance regarding the technicality of the technology and the recommendation for different tests and characterization of the devices with at least one step of AM fabrication. It also includes the information of the design and its manufacturing process, as well as the considerations in the testing of the devices. On the other hand, the guidance and draft made by the DFA is not applicable to processes in a more complex 3D printing and bio-printing, especially those that involve the human cells or tissues. The FDA focuses on two major areas regarding these medical devices, and they are the design and manufacturing process of the device, and its testing.
Aside from these, the FDA also pointed out that strict parameters are given full consideration whether the device is for standard use or for specific patient. Quality assurance is always a priority when recommending a device. The software is also of importance when discussing the design and it should be disclosed from the translation of the design to manufacturing one. According to the FDA, there are four steps involve on which the process is divided, such as the build volume placement, addition of support material, slicing, and creating build paths.
The FDA is not overly aggressive in stating the items in the guideline. What really is pointed out is the testing for performance and efficiency as how other non-3D printed devices are guided, although there is a big difference in the manufacturing process.
These draft and guidance are more on the elementary level, but as the innovation and technology of the 3D printing system continues to advance, the FDA will also create a more complex guideline as soon as every detail is considered. Since most of these devices are used in the medical field, for treatment or surgery, it is just appropriate for the FDA to provide such guideline.
The FDA includes in the guideline the issues about the cleaning, sterilizing, labeling, and bio-compatibility of the devices. As they become aware about the development of the 3D printing technology, and that more 3D printed devices continue to pile up getting approval from the agency, they will also pursue the furtherance of their coverage to ensure the quality and efficiency of each released and approved device.