FDA Regulations Coming Soon for 3D Printed Medical Devices?

3-D printed products, Additive Manufacturing (AM) as the technical term, are becoming increasingly popular and commonplace when manufacturing medical devices. Examples of 3-D printed devices include implants, surgical instruments, dental restorations, prosthetics, and much more. It’s forecasted that the 3-D printed medical device market will exceed $21 billion by 2020 according to MDDI’s Device Talk blog. Firms are cashing in on the craze, but the landscape is still uncharted in terms of regulation by the FDA.

In May, the FDA released a draft of guidance called, “Technical Considerations for Additive Manufactured Devices” spells out the framework for future regulations. The draft has raised a number of questions, who counts as the manufacturer? What’s the difference between something that’s still a work-in-progress (WIP) versus Finished Goods?

The first part of the document outlines the design and manufacturing considerations. This is aimed at providing technical considerations in order to fulfill the Quality System Requirements (QSR). It then talks about what should be included in a Pre-Market Application.

Design & Manufacturing Process Considerations

The vast majority of Medical Devices, including those employing AM techniques, must comply with the FDA’s QSR. This describes the process, procedures, and controls required for manufacturing Medical Devices. The regulations are complex, but allow flexibility for manufacturers when developing their own quality systems. Not all Medical Devices are equal, so relevant design, development, and manufacturing considerations must be made. The FDA strongly suggests manufacturers to develop production flow maps that identify the critical steps involved with manufacturing from beginning to end. It should address device design, software workflow, material controls, post-processing, process validation and acceptance activities, as well as quality data.

Additive Manufacturing does introduce variability to the design process. In this situation, the FDA recommends laying out a minimum size and tolerance for the device and components against the features that a finished product will have.

The FDA has also considered Patient-match, or “customized” devices that are developed from a standard template but matched to an individual patient’s anatomy. The manufacturer would need to spell out clinically-relevant design parameters and how the parameters will differ based on a specific patient. For those who use imaging software during the manufacturing process, the images must be clear and anatomic landmarks must be relatively apparent. Process validations will prevent small changes in size or geometry, which can lead to fitting issues. Since additional software and design revisits are often necessary, the FDA understands this. It breaks the process down into four steps and provides specific recommendations for each step. These steps include: build volume placement, addition of support material, slicing, and creating build paths.

The last thing the FDA spelled out was guidance on ensuring the proper calibration and machine settings, preventative maintenance, and how to control environmental conditions. These are important things to take into consideration during manufacturing, as they all can impact the quality of the device.

Pre-Market Device Testing

Specific information regarding quality system controls for devices have always been required in a 510(k) pre-market notification. As with any submission, the data required for application must include intended use, risk profile, and classification of the device. Testing of the device, normally required for traditionally manufactured devices, is also required. Additional support materials might include:

  • Device Description: For intermediate and customized devices without discrete sizes, a full profile of the device dimensions will be needed in addition to design variations, critical dimensions aka dimensions of features that are matched to a patient, type of technology used, and a flow chart describing the printing process.
  • Mechanical Testing: This is a performance test traditionally used for devices. A worst-case scenario of combinations of dimensions and features should be evaluated. Information about the device’s orientation build should be indicated in each performance test. If the build’s location has a significant effect on characteristics or performance, that must be indicated.
  • Dimensional Measurements: Dimensions may be affected by orientation and location in any given build space. Tolerances must be specified, and dimensional measurements need to be performed for each printed component to show consistency and reproducibility between build cycles.
  • Material Characterization: All material sources must be identified and recorded. Material properties that are historically known to affect inner-layer bonding should be characterized and representative of the final product.
  • Cleaning & Sterilization: Validated cleaning and sterilizing processes must account for complex geometrical devices under the identified worst-case conditions.
  • Additional Labeling Considerations: In addition to standard labeling requirements, labels for patient-matched devices must include: patient identifier, details about how to identify the use in a patient via an anatomical location, and the final design used to produce the device.

All of these considerations are necessary when manufacturing AM devices because of the various processes and techniques involved. This takes into consideration: powder fusion, stereolithography, fused filament fabrication, and liquid-based extrusion. In the past, the FDA has paid the most attention to the final produced device when reviewing 510(k) submissions. The FDA recognizes that the entire process must be put under a microscope and examined for adherence to QSR principles. Thus, a full profile of a device must pass several tests and fulfill a full breadth of requirements. The FDA does not count software used for drafting as having to be validated or have any regulation stipulations. This could change in the future.

InstantGMP™ MD is a software solution designed for manufacturers of Medical Devices to comply with the FDA’s Quality Service Regulations in addition to 21 CFR Part 11 for Electronic Documentation and ISO 13485. InstantGMP™ MD offers the flexibility needed by manufacturers of 3-D printed devices, and is a cost-effective solution to traditional Medical Device manufacturers. Be sure to check out our SOPs for Medical Device manufacturers and we invite you to sign up for a demo, we’ll show you how our software can integrate with your current process.