Tag Archives: biomedical 3D printing regulatory issues

FDA’s Initial Thoughts on 3D Printing of Medical Devices Published Today

Curious about how regulations on 3D printing of medical device will evolve? Check out the draft guidance published today by the United States Food and Drug Administration (“FDA”). Comments and suggestions are welcome and should reach the FDA within the next 60 days.

The draft guidance looks interesting under a number of aspects. First of all, it provides a definition of additive manufacturing (“AM”), i.e., “a process that builds an object by iteratively building 2-dimensional (2D) layers and joining each layer below, allowing device manufacturers to rapidly alter designs without the need for retooling and to create complex devices built as a single piece.”

It also defines itself as a “leap-frog guidance” and clarifies that “leap frog guidances are intended to serve as a mechanism by which the Agency can share initial thoughts regarding emerging technologies that are likely to be of public health importance early in product development”, which is a nice way to say that the FDA recognizes that its thoughts are just initial and subject to change.

A number of caveats are singled out and manufacturers are invited to be careful about, and to design their quality systems so they take due account of:

  • device design, which can be altered in AM due to various factors (pixelation of features, various patient-matching techniques, effects of imaging, etc.)
  • software and software interactions;
  • machine parameters and environmental conditions;
  • material used (which can be raw material or recycled);
  • post-processing phase;
  • process validation and acceptance activities;
  • device testing;
  • cleaning and sterilization;
  • biocompatibility.

The FDA also believes that AM devices that are patient-matched should be subject to additional labelling information.

The draft guidance does not address the use or incorporation of biological, cellular, or tissue-based products in AM, which may require additional regulation. Also, point-of-care device manufacturing may raise additional technical considerations.

3D Printing In Healthcare: Regulatory Issues To Consider

The Democratization of 3d Printing: Joys and Sorrows

A fascinating technology is becoming more and more widespread and may completely change the world of manufacturing as we know it: 3D printing. An object passed through a 3D scanner or a file downloaded through the internet may enable almost anybody to produce an unlimited number of 3D copies.

This is a classic example of an innovative technology that is going through the process of “democratization”: with the price of 3D printers now in the range of tens of thousands of Euros, a manufacturing method, which was once available only to a few, may now be found in every architecture firm, in your garage and… in your hospital.

A beautiful National Geographic title points to the revolutionary aspects of 3D printing: “As epoch-making as Gutenberg’s printing press, 3-D printing is changing the shape of the future.” As in many other “revolutions”, it is difficult to imagine its full potential at its onset. Therefore, 3D printing sparks both enthusiasm and anxiety. Many intellectual property owners have much to fear from the possibility of producing countless unauthorized copies of products looking exactly like theirs. While the music and movie industries already suffered when home taping or file sharing became commonplace, 3D printing may impact nearly all industries. Others point to the risks connected with the complete lack of control over the production of guns or other dangerous objects (with others questioning how serious of a threat this might be).

3D printing is already vastly used in the field of medical practice, and many more uses can be imagined in the future (printing organs for transplants is no longer an entirely futuristic scenario). Recent research on 3D programs deployed in Italian hospitals point to the advantages related to 3D models of patients for pre-surgery planning, for training, as well as for obtaining the patient’s informed consent. None of such uses are likely to trigger legal or regulatory issues, if data protection aspects are correctly handled.

Is 3d Printing a Regulated Activity? Is a 3d Printed Item a Regulated Object?

If, instead, a 3D object is created and used closer to patients, it is possible that a regulated item is obtained (most likely a medical device or an advance therapy medicinal product), or that a regulated activity is carried out, with a host of regulatory consequences. In fact:

3d Printing and Liabilities

Who is responsible if a 3D printed medical object is defective? The process of 3D printing involves a number of potentially responsible individuals, who may be liable, in full or in part. A Court would have to determine what went wrong. Depending on the circumstances, the doctor prescribing the 3D object, the surgeon implanting it, the radiologist choosing the images on which the 3D printing process is based, the manufacturers of the 3D printer or of the materials used, the user of a 3D printer… each of them may be responsible for the defect.

However, this is not a new scenario in medical technology, where product liability is always potentially connected with medical malpractice and where finding out the exact responsibility of each subject can be challenging. Italian law sets forth joint liability of all responsible persons and indicates that the person who paid damages has recourse against the other liable persons on the basis of risks, faults and consequences. If such allocation of liability is not possible, then each person is liable in equal parts.


There is often a general sense that an innovative technology is so new that it happens in a legislative vacuum, because how could the legislator have already foreseen rules specific to 3D printing? We have written about a similar approach in the field of medical apps. Instead, new technologies typically land on a pre-existing landscape of applicable regulations, which should be taken into account by innovators and users of innovation. Regulatory authorities may not be ready to start enforcement actions against 3D printing, but may decide to do so in the future.