December 14, 2021
A new discussion paper from the US Food and Drug Administration identifies challenges to developing effective regulatory oversight of 3D printed medical devices used in patient point of care (PoC) settings, and lays out potential regulatory approaches for such devices.
The FDA discussion paper also serves as a call for comment from stakeholders such as 3D printed medical device manufacturers, healthcare facilities (HCF) and providers regarding the agency’s initial regulatory proposals and related issues; stakeholders have through February 8, 2022 to submit comments.
Challenges for oversight 3D printing at the point of care
FDA’s scope in its discussion paper pertains to medical devices that are 3D printed in the vicinity of a patient, in PoC facilities such as hospitals, surgical facilities and physicians’ offices. Medical devices produced via 3D printing or additive manufacturing in facilities other than PoC sites do not fall under the scope of FDA’s discussion paper.
In terms of evaluating 3D printed device safety and effectiveness at the PoC as well as ensuring effective regulation of these products, FDA lists several challenges:
- FDA must assure safety and effectiveness of medical devices including 3D printed devices at the PoC regardless of where or how devices are manufactured;
- Approaches for determining appropriate controls for device design and manufacturing are well-established for conventionally manufactured devices, but less so for 3D printed devices in PoC settings;
- The need to clarify responsible entities responsible for device life cycles is more complicated for 3D printed devices at the PoC, as entities performing additive manufacturing at the PoC may not be fully aware of or understand requirements such as FDA premarket clearance or approval, quality control and management, adverse event reporting or corrective actions;
- In terms of PoC training and capabilities, entities that perform 3D printing of devices at the PoC should possess adequate knowledge and expertise regarding issues including patient matching, post-processing activities as well as risk characteristics of the devices they’re producing.
Proposed FDA regulatory approach for 3D printed devices at the PoC
Bearing in mind the challenges listed above regarding oversight of 3D printed devices manufactured at PoC sites, the FDA discussion paper outlines potential steps for developing a regulatory approach that takes into account the characteristics and complexities specific to these devices.
First, FDA would utilize a risk-based approach wherein the extent of the agency’s oversight would track the level of risk associated both the 3D printed medical device itself as well as the 3D printing process at the PoC for that device.
Second, the agency would require that manufacturing sites or locations should not impact manufacturers’ ability to meet predetermined device specification requirements.
Third, PoC HCFs that perform 3D printing of devices must implement and practice capabilities, oversight, training and related processes and procedures necessary to minimize production risks.
Fourth, entities involved in 3D printing of devices at PoC sites should have a clear understanding of their compliance obligations under US law and medical device regulations.
Fifth, additive manufacturers at PoC sites should utilize least burdensome approaches such as existing standards in order to provide reasonable assurances that their 3D printed devices meet requirements for safety and effectiveness.
The discussion paper also includes potential scenarios that could impact how FDA regulators address 3D printed device oversight at the PoC, as well as several related questions for stakeholders in terms of 21 CFR Part 820 quality management system compliance, reporting obligations as well as whether parts of the agency’s existing medical device regulatory framework could effectively apply to oversight of this emerging sector.
Learn more about US FDA medical device regulations at Emergo by UL:
- US FDA 510(k) consulting for medical device and IVD manufacturers
- FDA Quality System Regulation (QSR) support for medical device companies
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