Additive manufacturing, the FDA and a regulatory minefield

Even though additive manufacturing has opened the door to multiple business opportunities in recent times it has been like the Wild West for the last few years… no laws or regulations to talk of despite the fact this technology is impacting many areas of our everyday life. Where are the regulators when you really need them?

Additive manufacturing

FDA to the rescue

The FDA has stepped in and produced draft guidelines for medical device manufacturers who plan on using 3D printing. The purpose of the draft guidelines is to open a discussion involving all relevant parties you will have input into the FDA’s final decision on the long term regulatory structure. These broad guidelines have started out fairly simple but they will eventually become more detailed and all encompassing.

Draft regulations for additive manufacturing

The draft regulatory structure will only cover those using additive manufacturing to create devices for the medical profession. It has initially been separated into two separate topic areas: Design and Manufacturing Considerations (Section V) and Device Testing Considerations (Section VI). The specifications cover subjects like materials, sterilization, cleaning, biocompatibility, resolution and software.

FDA Additive manufacturingSince print orientation, material type, build environment, dimensions and an array of other factors can all impact the performance of any medical device, the FDA will take these and more into consideration. A universal testing structure will ensure that all 3D printed medical devices are safe to use in their relevant fields and all of similar high quality. It has also been recognised that errors in the file conversion process can negatively impact the finished device and the property of the various components, such as dimensions and geometry. As a consequence, post processing and software will also be included in the regulatory structure when evaluating and testing medical devices.

The future of additive manufacturing

In short the FDA wants all environmental factors and inputs (physical and software) to be recorded, measured and tested. The specific settings and how they can be manipulated are still under consideration with no final decision until all relevant parties have had their input. According to the FDA’s guidance documents, they “do not establish legally enforceable responsibilities. Instead, they describe the agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited”. Specific guidance covering the many different uses of additive manufacturing will emerge over the coming months and years as this groundbreaking technology continues to develop.



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