Posted: 02 Jan 2018 06:37 PM PST
On December 5, 2017, FDA issued a final guidance: Technical Considerations for Additive Manufactured Medical Devices, Guidance for Industry and Food and Drug Administration Staff. Additive Manufacturing (AM) is “a process that builds an object by iteratively building 2-dimensional (2D) layers and joining each to the layer below, allowing device manufacturers to rapidly alter designs without the need for retooling and to create complex devices built as a single piece.” This includes so‑called 3D printing. FDA issued a draft of this guidance in May 2016, as discussed in our prior blog post here. This post discusses the main differences between the draft and final guidance. For a more in depth overview of the entire content, please refer to the prior blog post.
The guidance provides insight into the unique considerations of AM manufacturers in complying with quality system regulations and device testing considerations (i.e., premarket submission considerations). FDA Commissioner Scott Gottlieb, M.D. issued a statement concurrently with release of the guidance, highlighting that, with this guidance, the “agency is the first in the world to provide a comprehensive technical framework to advise manufacturers creating medical products on 3D printers.” Commissioner Gottlieb also stated that the intention of the guidance is to “help manufacturers bring their innovations to market more efficiently by providing a transparent process for future submissions and making sure our regulatory approach is properly tailored to the unique opportunities and challenges posed by this promising new technology.”
As with the draft, this guidance notes that it is a leapfrog guidance, where the Agency can share initial thoughts regarding emerging technologies that are likely to be of public health importance early in the product development. The Agency notes that the recommendations contained in this guidance may change as more information becomes available.
Noteworthy Changes from the Draft Guidance
The final guidance contains some changes from the draft that are worth highlighting. One of the most notable changes was the inclusion of additional issues in the section regarding Patient-Matched Device (PMD) Designs. These are products that are matched to a patient’s anatomy. The finalized guidance includes a section on complex design files and files and cybersecurity and personal identifying information not found in the draft.
Complex Design Files
The guidance notes that PMDs that follow the patient’s anatomy are vulnerable to errors in file conversion because they involve complex anatomic curves that can create difficulties when calculating conversions. The guidance recommends that manufacturers of PMDs follow considerations on maintaining data integrity throughout file conversions.
Cybersecurity and Personal Identifying Information
The guidance does not go into detail on the cybersecurity implications of PMDs, noting that the topic is beyond the scope of the guidance. Instead, the document refers readers to the HHS Guidance on Significant Aspects of the Privacy Rule and Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.
Risk-Based Approach to Imaging Data
Other notable changes specific to PMDs are that manufacturers should be employing a risk-based approach when incorporating imaging data into the final design. The guidance advises manufacturers to take into consideration the intended use of the device and the design methodologies to assess the scenarios that may yield a worst-case match.
Test Coupons
A final notable addition involves the use of test coupons in AM devices. A test coupon is a representative test sample of a device or component. The draft guidance noted the importance in the design of test coupons and placement within the build volume in the context of AM and recommended the use of coupons to help with process validation and for in-process monitoring. The final guidance clarifies that test coupons may not be needed if the process is validated per QSR requirements and coupon testing is not a process monitoring activity defined in your quality system.
Because of the nature of this technology and the fact its clinical applications are relatively new to the Agency, we recommend that manufacturers of AM devices seek feedback from FDA on their specific device early in the submission planning process.
Additional Thoughts
The final guidance fails to provide any insight into decision-making on whether or not to file a new 510(k) for modifications to a device or the manufacturing process of an AM device, a major issued we identified in our discussion of the draft guidance. Additionally, the final guidance does not address who FDA considers to be an AM device manufacturer, generally referring to manufacturers without specifically defining what that label encompasses. This is important because there are many entities that would not be considered manufacturers in the traditional sense, but could arguably be considered AM manufacturers. For example, if a hospital obtains a 3D printer and creates a device (based on cleared specifications) specific to a patient’s anatomy, does that act make it a manufacturer subject to these requirements? The answer is not clear. Notably, however, Commissioner Gottlieb acknowledged in his statement that more insight from the Agency in needed on the topic of who is an AM manufacturer: “Developing a transparent policy on 3D printing remains an important next step for us, and we plan to explore the role of nontraditional manufacturing facilities like a hospital operating room or university laboratory.” Hopefully the Agency will provide more clarity on this topic soon.
The guidance provides insight into the unique considerations of AM manufacturers in complying with quality system regulations and device testing considerations (i.e., premarket submission considerations). FDA Commissioner Scott Gottlieb, M.D. issued a statement concurrently with release of the guidance, highlighting that, with this guidance, the “agency is the first in the world to provide a comprehensive technical framework to advise manufacturers creating medical products on 3D printers.” Commissioner Gottlieb also stated that the intention of the guidance is to “help manufacturers bring their innovations to market more efficiently by providing a transparent process for future submissions and making sure our regulatory approach is properly tailored to the unique opportunities and challenges posed by this promising new technology.”
As with the draft, this guidance notes that it is a leapfrog guidance, where the Agency can share initial thoughts regarding emerging technologies that are likely to be of public health importance early in the product development. The Agency notes that the recommendations contained in this guidance may change as more information becomes available.
Noteworthy Changes from the Draft Guidance
The final guidance contains some changes from the draft that are worth highlighting. One of the most notable changes was the inclusion of additional issues in the section regarding Patient-Matched Device (PMD) Designs. These are products that are matched to a patient’s anatomy. The finalized guidance includes a section on complex design files and files and cybersecurity and personal identifying information not found in the draft.
Complex Design Files
The guidance notes that PMDs that follow the patient’s anatomy are vulnerable to errors in file conversion because they involve complex anatomic curves that can create difficulties when calculating conversions. The guidance recommends that manufacturers of PMDs follow considerations on maintaining data integrity throughout file conversions.
Cybersecurity and Personal Identifying Information
The guidance does not go into detail on the cybersecurity implications of PMDs, noting that the topic is beyond the scope of the guidance. Instead, the document refers readers to the HHS Guidance on Significant Aspects of the Privacy Rule and Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.
Risk-Based Approach to Imaging Data
Other notable changes specific to PMDs are that manufacturers should be employing a risk-based approach when incorporating imaging data into the final design. The guidance advises manufacturers to take into consideration the intended use of the device and the design methodologies to assess the scenarios that may yield a worst-case match.
Test Coupons
A final notable addition involves the use of test coupons in AM devices. A test coupon is a representative test sample of a device or component. The draft guidance noted the importance in the design of test coupons and placement within the build volume in the context of AM and recommended the use of coupons to help with process validation and for in-process monitoring. The final guidance clarifies that test coupons may not be needed if the process is validated per QSR requirements and coupon testing is not a process monitoring activity defined in your quality system.
Because of the nature of this technology and the fact its clinical applications are relatively new to the Agency, we recommend that manufacturers of AM devices seek feedback from FDA on their specific device early in the submission planning process.
Additional Thoughts
The final guidance fails to provide any insight into decision-making on whether or not to file a new 510(k) for modifications to a device or the manufacturing process of an AM device, a major issued we identified in our discussion of the draft guidance. Additionally, the final guidance does not address who FDA considers to be an AM device manufacturer, generally referring to manufacturers without specifically defining what that label encompasses. This is important because there are many entities that would not be considered manufacturers in the traditional sense, but could arguably be considered AM manufacturers. For example, if a hospital obtains a 3D printer and creates a device (based on cleared specifications) specific to a patient’s anatomy, does that act make it a manufacturer subject to these requirements? The answer is not clear. Notably, however, Commissioner Gottlieb acknowledged in his statement that more insight from the Agency in needed on the topic of who is an AM manufacturer: “Developing a transparent policy on 3D printing remains an important next step for us, and we plan to explore the role of nontraditional manufacturing facilities like a hospital operating room or university laboratory.” Hopefully the Agency will provide more clarity on this topic soon.
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