Dec 5, 2017 | By Benedict

The U.S. Food & Drug Administration (FDA) has published its long-awaited guidance for 3D printed medical devices. The technical document represents the FDA’s “initial thoughts” on additive manufacturing, and is part of the administration’s effort to build a regulatory framework for AM.

It seems like an age since the FDA first published its draft guidance for 3D printed medical devices. That initial sketch appeared in May 2016, allowing big companies from medicine and 3D printing like AdvaMed, Johnson & Johnson, and Materialise to offer their thoughts on the guidelines in the form of official comments.

16 months on from the passing of the comments deadline, the FDA has now published its non-draft guidance for 3D printed medical devices, taking into account the suggestions made by those major organizations as well as independently observed developments that have taken place over the last year or so.

The document isn’t intended to be conclusive. Rather, the FDA calls the guidance its “initial thoughts” on the additive manufacturing process, the first step in the formation of a regulatory framework for the production of 3D printed medical devices.

The guidance, as its name suggests, is not so much a black-and-white rulebook as a detailed list of suggestions for medical device manufacturers. It serves to let companies know what the FDA is looking for in terms of device design, testing of products for function and durability, and quality system requirements. Meet the FDA’s targets, and companies are much more likely to have their 3D printed device approved for medical use.

FDA-produced flow chart of the additive manufacturing process

The document is divided into seven parts, two of which are of particular interest: “Design and Manufacturing Process Considerations” and “Device Testing Considerations.” The design and manufacturing section covers topics like patient-matched device design, material controls, and post-processing, while the testing section outlines guidance on mechanical testing, material characterization, biocompatibility, and more.

A key caveat of the new FDA 3D printing guidance is the acknowledgement that the document—like 3D printing itself—is a work in progress. FDA Commissioner Scott Gottlieb M.D. commented that the FDA’s recommendations are “likely to evolve as the technology develops in unexpected ways,” noting recent examples like biodegradable 3D printed airway splints as evidence that new 3D printed innovations are coming thick and fast.

With that caveat, however, comes the admission that many things are still being worked out by the FDA. For example, the administration says it is still considering how best to approach the matter of “nontraditional manufacturing facilities” like hospital operating rooms or university laboratories, where 3D printers can be used to create on-the-spot 3D printed medical devices.

FDA-approved 3D printed surgical guides from Materialise

Another big area of medical 3D printing that needs further review is 3D bioprinting. The FDA says it’s planning to review the regulations surrounding biological, cellular, and tissue-based products, and will then choose whether this subcategory of devices requires an additional publication. (The FDA published a “policy framework” on regenerative medicine in November, which contains some guidance on bioprinting.)

The FDA says it has reviewed more than 100 3D printed medical devices to date, some of which received eventual approval and some of which did not. These devices, the administration says, included things like implants and Spritam, the now-famous 3D printed drug for epilepsy. In the future, it expects to see things like 3D printed wound treatments for burns victims and even 3D printed replacement organs.

In order to better understand the 3D printing process and its relationship to medical devices, the FDA has its own “state-of-the-art 3D printing facilities,” allowing experts from the Center for Drug Evaluation and Research’s (CDER) and Center for Devices and Radiological Health (CDRH) to conduct research on 3D printed drugs and 3D printed devices, respectively.

The full FDA document, “Technical Considerations for Additive Manufactured Medical Devices,” can be read here.

 

 

Posted in 3D Printing Application

 

 

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