By Leah S. Poniatowski, J.D.
In light of the vast opportunity and regulatory challenges additive manufacturing (AM) presents to the medical device industry, the FDA released an outline of technical considerations for industry and FDA staff. The "leapfrog" guidance covers design and manufacturing considerations, device testing considerations, and labeling (Notice, 82 FR 57462, December 5, 2017).
In general. The guidance reflects the FDA’s "initial thinking" on the subject of AM, more commonly referred to as 3D printing, for medical devices. The FDA held a public workshop in October 2014 and the feedback from that event provided the framework for the guidance. The Agency clarified that the guidance is non-binding and provides a general outline, and that the FDA is cognizant that the recommendations may change in light of developments in the industry. The FDA also acknowledged that the guidance is not exhaustive and includes frequent references to other government offices and publications throughout for manufacturers with more detailed inquiries.
Design and manufacturing considerations. The FDA’s guidance touched on seven aspects of design and manufacturing considerations which are part of fulfilling Quality System requirements for regulated devices. The Agency expects AM-manufactured devices to generally follow the same regulatory requirements as for non-AM devices, and emphasized the importance of documentation and identification of the key/critical aspects of an AM-device’s design and manufacture. With respect to overall device design, the focus of the FDA recommendations were to ensure reliable building.
For patient-matched device designs, clinically relevant design parameters, their ranges, and which can be modified for patient-matching should be identified, in addition to addressing: the effects of medical imaging, interacting with design models, possible file conversion errors/data integrity, and cybersecurity/safeguarding personally identifiable information. Software workflow considerations are also important, particularly mitigating file format conversion errors, successful use of build preparation software when bridging the design stage to the manufacture stage, and validation/automating software processes. With respect to material controls, the FDA provided guidance on the starting material and the re-use of material. The FDA also provided guidance on post-printing manufacturing processes, validation and acceptance processes, and quality data.
Device testing considerations. For the premarket device submission phase, the FDA provided guidance on six areas of the process. The first emphasized the importance of documentation of the AM process, and identifying dimensions and critical features. Second, mechanical testing would follow that of traditional manufacturing with consideration of aspects unique to AM (e.g., orientation, build space location). Dimensional measurements also should be specified. With respect to material characterization, all materials, expected material chemistry changes, and material properties impacting interlayer bonding, among other physical properties should be identified. Manufacturers should also address removing manufacturing material residues and sterilization. Finally, biocompatibility of an AM device should be analyzed.
Labeling. The FDA recommends following all applicable rules for labeling, in addition to adding labels identifying the patient, use, and final iteration/version used in the production for patient-matched AM devices, among other recommendations.
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