FDA has published a detailed draft guidance on regulation of 3D printed devices. Offering detailed advice on both design and manufacturing and on device testing, the guidance exposes the agencies “initial thinking” on regulatory controls for 3D printed devices.
Additive manufacturing (more commonly called 3D printing” presents some particular challenges. This technology is most commonly used to create custom devices. Although its use in production of stock devices is becoming more widespread because of the benefits offered in manufacture of more complex shapes and forms. IN custom devices particularly, the design process has to be considered at two levels – the overall design of the device type- and the individual custom design of each specific device for each specific, named patient. The trick is to understand the broader constraints and limits of the overall design within which customisation can occur. That requires a thorough understanding of the engineering of the device to enable the manufacturer to identify (and justify) the limits .
There’s plenty of food for thought in this guidance. it covers Matters ars device as materials characterisation and selection – and recycling of materials, software aspects of converting from digital designs to tangible designs, as well as the more conventional considerations of biocompatibility, labelling and cleaning and sterilisation.
What is a “Leap Frog Guidance anyway? To quote FDA: “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”. Choose your metaphor – they are a means by which FDA can fly a kite, send up a test balloon, test the waters… These are FDA’s initial thoughts, they invite your comment at http://www.regulations.gov.
Unlike many other international jurisdictions, the US FDA regulates commercially produced custom devices through the conventional 510(k) regulatory clearance process. This means that the regulatory infrastructure already exists to control the supply of 3D printed devices. The challenge is likely to be more one of awareness, of new settings for use and for combination with other regulated products, especially biologics. 3D printers are finding their way in to the point of care setting to produce custom devices at the operating theatre. Clinical users may not always be aware of their responsibilities under FDA regulation. When 3D printers are used in conjunction with autologous cells for tissue engineering, things start to get really interesting…
Download a copy of the guidance here. See the Federal register announcement and call for comments here. Or go directly to http://www.regulations.gov. to file your comments.
Developing 3D printed or other custom devices? We have direct experience of international regulatory submissions for custom devices. Contact us or email firstname.lastname@example.org or call +61 2 9906 2984. We would be pleased to discuss how we can help you.