Indeed, said Rubenstein, “The FDA’s approval preempts any state law claims for design and warning defects, to the extent that the state law claims attempt to impose duties in addition to, or different from, those under the federal law.”
The FDA’s approval, clearance or license gauntlet is, in terms of product liability risk, a blessing for manufacturers and their hospital, clinic and physician customers.
But 3D printing introduces a whole new set of variables into the manufacturing, testing and validation process. As a result, new product liability risks may not be covered by an FDA safety blanket.
Again, referring to Rubenstein’s analysis, here are three new risks that come with the 3D revolution:
- Who regulates the computer-aided-designer (CAD) or the 3D printer? If a software glitch, an internet hiccup or a big truck rumbling down the street shakes the 3D printer and alters an implant, will FDA compliance still protect the manufacturer? “Or, to take it one step further, should the FDA extend its regulation to the CAD designers and the 3D printers?” said Rubenstein in his blog.
- Since designs are CAD-based and, potentially, infinitely variable since they can be derived from each patient’s unique anatomy, will the present case law based proposition that strict liability design defects are barred as a matter of law still stand?
- And finally, where’s the Instructions for Use (IFU) for the software, 3D printer, imaging device or raw material?
Indeed, using a 3D printing system to create an implant even challenges some of the FDA’s traditional classification systems. Where, for example, is the predicate device?
To contact Mr. Rubenstein directly: richard.rubenstein@wilsonelser.com
Five Takeaways From the FDA 3D Printing Guidance Document
- FDA wants to work with Industry and build off of the existing medical implant approval/clearance/license processes.
So many new issues are raised by 3D printing that the FDA wants industry to be an active collaborator in developing guidelines—BUT—the FDA would like to follow the same regulatory requirements and submission classification and regulation guidelines for additive manufactured devices as for traditionally manufactured devices.
The FDA strongly encourages manufacturers to engage CDRH (Center for Devices and Radiological Health) or CBER (Center for Biologics Evaluation and Research) through the Pre-Submission process for any 3D printed device or drug.
Class II and Class III 3D devices and some Class I 3D devices must still meet 21 CFR 820.30 Design Controls to ensure that the 3D printed devices perform as intended.
- Patient matched 3D implants are a whole new kettle of fish.
After reading the FDA document, the real question is: What can’t go wrong?
The new risk variable list goes like this:
- Anatomic features that are not accurately imaged or are not consistent over time may result in a 3D fabricated implant that does not fit well in the patient.
- Small changes in size or geometry are hard to spot during visual inspection or through patient imaging so mismatched implants could sneak past quality control (QC).
- Devices intended to fit to or match soft tissues and non-rigid structures may be affected by deformation at the target implant location.
- Anatomy changes over time (e.g., with disease progression) and that may affect a patient-matched implant. Need an expiration date? Or explant date?
- Devices that follow patient anatomy precisely are vulnerable to software errors in file conversion. There are NO straight lines in human anatomy—which means that the software algorithms which convert anatomic curves into geometric designs are mathematically complex—and, therefore, vulnerable.
The FDA is urging suppliers to really nail down their clinically relevant design parameters, pre-determine a min/max range for these parameters and highlight which of those parameters get modified for patient-matching.
The FDA is also serious about expiration dates on patient matched implants.
