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 Check out the draft guidance published today by the United States Food and Drug Administration (“FDA”).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The draft guidance looks interesting under a number of aspects.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;
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The draft guidance does not address the use or incorporation of biological, cellular, or tissue-based products in AM, which may require additional regulation.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.