The FDA is currently overregulated

FDA guidelines for 3D printed medical products

The American FDA (Food and Drug Administration) has issued guidelines for 3D-printed medical devices. These are not yet binding, but could represent a first step towards the legal regulation of 3D-printed medical devices.

3D-printed medical devices are a very hot topic in medicine. It is therefore not surprising that the FDA is looking into the matter. In December became acomprehensive technical frameworkcreated. In other words, guidelines for manufacturers of medical devices, which they do not (yet) have to adhere to.

The guidelines are intended to help manufacturers bring innovations to market efficiently. However, the guidelines may also be a preparation for statutory regulations that manufacturers must adhere to.

The FDA is the main agency at the moment looking to regulate 3D printing

However, there are also concerns: Overregulation could mean that innovations in the field can no longer be implemented as quickly. The aim is to ensure patient safety while not slowing down the speed of innovation too much. The European Union is also working on similar guidelines (current status).

The concern related to overregulation is that it could stifle technological advancement. We need to assure the public is safe when using technology

The FDA has already assessed over 100 3D printed medical devices. The first 3D-printed drug was also successfully tested by the FDA.

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Dominik is currently studying business informatics at the Vienna University of Technology. For several years he has been working with new technologies and especially with 3D printing. In his free time, Dominik also deals with embedded systems and their programming and also works on a voluntary basis for several organizations.