Medical device manufacturers who will use additive manufacturing (AM)—including three-dimensional (3D) printing—now know the FDA’s initial thoughts about how it will eventually regulate the emerging technology, thanks to a new “leap-frog” draft guidance. The agency believes that AM will be important to the public health, and wants to provide manufacturers with its recommendations in the early stages of product development. The draft guidance covers Design and Manufacturing Considerations and Device Testing Considerations; it does not address the use or incorporation of biological, cellular, or tissue-based products in AM (Notice, 81 FR 28876, May 10, 2016).
Additive manufacturing. AM is a process that builds a 3D object by joining multiple two-dimensional layers together, which allows device manufacturers to rapidly alter designs. In medical device applications, AM can use a patient’s own medical imaging to create anatomically-matched devices and surgical instrumentation. It also allows manufacturers to build complex devices that would not be easily possible using traditional (non-additive) manufacturing approaches, such as engineered open lattice structures, tortuous internal channels, and internal support structures.
AM is experiencing both rapid technological advancements and the increased availability of necessary fabrication equipment. Investments in AM technology are increasing, as are the uses of AM in medical devices. According to the FDA, the unique aspects of the AM process pose challenges in determining optimal characterization and assessment methods for the final finished device, as well as optimal process validation and verification methods for these devices.
Draft guidance. According to the FDA, the AM technologies most commonly used in the manufacture of medical devices are powder fusion, sterolithography, fused filament fabrication, and liquid-based extrusion. The draft guidance outlines technical aspects for consideration during the phases of development, production, process validation, and final finished device testing for AM devices. In general, the agency anticipates that AM devices will be subject to the same classification and regulatory requirements as non-AM devices of the same type. The FDA expects that there will be challenges in achieving adequate cleaning, sterility, and biocompatibility for AM devices.
Design and manufacturing considerations. It is important for AM device manufacturers to have a production flow diagram identifying all critical steps involved in the manufacturing of the device to ensure product quality. Further, there should be a high-level summary of each critical process step. The minimum possible feature size of the AM technique should be compared to the desired feature sizes of the final finished device to ensure the reliable building of devices and components. The draft guidance also includes information on potential problems in the manufacture of AM devices of which manufacturers should be aware and take note.
The FDA notes that patient-matched AM devices, commonly referred to as “customized” devices, generally do not meet the custom device exemption (21 U.S.C. §360j(b)) in the federal Food, Drug & Cosmetic Act (FDC Act). AM device manufacturers should refer to the FDA’s guidance on the exemption to determine whether their device qualifies.
Device testing considerations. For the premarket submission of an AM device, the FDA says that the type and amount of data to support a substantial equivalence determination or approval varies on the device type. However, generally, AM device manufacturers should do the following:
- identify the range of dimensions for the device;
- include a flow chart describing the AM process;
- conduct performance testing on final finished devices;
- provide a baseline study of the machine/material combination used; and
- account for the complex geometry of the device in cleaning process validation and sterilization process validation.
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