The advances 3D printing/additive manufacturing is bringing to the field of medicine are transformative. And the FDA has noticed.
The FDA has become very involved in 3D printing, hosting a 3D printing workshop at the end of 2014, and working with several additive machines to get an understanding of what’s critical and what’s not.
The agency is working with the industry to get medical innovative designs to market.
But as more designs shift from custom to off-the-shelf, the FDA has chosen to issue guidance.
As early as 2007, the FDA issued letters to several medical device companies that additively manufactured products that could fit Class II classification and be cleared in a pre-market approval process, or 510K.
The FDA has an education page on its website that covers where the agency advisors are in developing regulation for this ever growing market.
In addition, they have developed specific guidance–Technical Considerations for Additively Manufactured Devices. This guidance is meant to be a series of drafts that will evolve. A draft guidance is not law. It is open for public comment for several months, then put in a more final form.
This guidance document extensively speaks about technical considerations to address to fulfill the quality system requirements for your devices. No one is exempt from meeting the quality system requirements for a medical device. So if a design, by its purpose, is determined to be a Class II or Class III device, then it needs to follow and comply with the quality system requirements established through the FDA.
The guidance notes several pieces of information the FDA requires. If a device is not class 1 exempt, then the FDA wants to know all critical steps involved in the manufacture of the device. Risks must be identified for each step of the manufacturing process as well as mitigation of the risks. How the device could impact the patient and how it could impact a procedure. Information on software may also be needed. The FDA wants to know what will happen if software does not perform correctly, what risk could be presented by that failure.
For custom devices, the FDA has a Custom Exemption Guidance document that gives more specifics. The FDA primarily sees two paths. One involves off-the-shelf type designs. The other involves patient matched or custom specifically to be used in one case on one patient.
In patient matching situations the FDA is interested in seeing and approving for a range instead of finite elements or a finite set of sizes for off the shelf type products. In this situation, you can make a cutting guide or a custom implant in this set of ranges and show the design parameters are controlled but for only specific sizes.
FDA guidance, like the additive manufacturing industry itself, is an ever evolving, changing landscape. New information is coming out monthly.
Design World magazine recently held a webinar on FDA requirements for additive manufacturing. Kim Torluemke, VP of Quality & Regulatory, Healthcare, at 3D Systems gave the presentation. To view the webinar, click here.
Leslie Langnau
llangnau@wtwhmedia.com
