The regulatory requirements of 3D printing medical devices at the hospital

Taking into consideration all the regularities that the hospital has to get through before beginning to print out the devices, it’s important to be aware of them before beginning to implement the process. This involves mainly FDA regulations, which include the materials printable devices are made of, testing the product, and their performance. Some authorized certification from the regulatory agency must be needed as well.

More and more hospitals decide to implement 3D printing point-of-care, because it simply enables them to provide devices in a more innovative, fast and time-efficient way. However, the whole procedure still needs to be cleared out by the FDA. This would also include hardware and software. After ensuring that the devices produced are safe and effective, they are ready to be put on the market and used. However, the device is not considered to be FDA product.

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FDA regulatory according to hospitals 3D Point-Of-Care

After the printed model will be accepted and considered as a medical device by the FDA. The next steps are not followed by the FDA anymore. In the case of the company, which intents to sell the printable products, the manufacturer needs to get registered, complete all the FDA qualities, list and receive the pre-market approval first.

This also means that the hospitals, which decide to implement point-of-care 3D printing lab by themselves, have more to say and less to do about the FDA requirements. They are more independent than 3D manufacturers, which need to ensure the fulfillment of many more regulations.

The clearance from the FDA side should be assured, but most of the process can be control by the medical professionals and not much interference in the whole process is actually necessary.

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Hospitals in the role of 3D manufacturer

The regulations are still not clear enough in general, however, when implementing 3D point-of-care outside of the U.S it’s more dependent on the local authorities’ decisions instead of relying on FDA assistance.

Different countries may have different perspectives for implementing 3D printing point-of-care at their medical centers, however, this is not changing the fact that this should be still conducted in accordance with all the standards and regulations.

In order to be able to put the 3D printed devices on the market, safety and effectiveness demands have to be achieved and authorized by the regulatory organization.

Does it sound complicated for you? Would you be able to fulfill the following requirements? Share with us your opinion in the comment below!


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