Developing technologies in manufacturing, patient-matching and timely personalized patient care have identified the need to establish guidance and policy around the regulatory responsibilities of entities engaging in Point of Care (PoC) 3D printing. On December 10, 2021, the U.S. Food and Drug Administration (FDA) released a discussion paper regarding 3D printing medical devices at the PoC as a first step in the process, with the goal of gathering early public input. The intention is to facilitate input from industry to further develop a Center for Devices and Radiological Health (CDRH) guidance and not to communicate any current policy, as stated within the disclaimer displayed at the beginning of the paper.
Within the discussion paper, some of the regulatory challenges that come with 3D printing at the PoC as opposed to traditional manufacturing operations at a medical device manufacturing site are reviewed. Concepts around proposed oversight approaches are also presented, seeking input from the public on a set of discussion questions.
Challenges with PoC 3D Printing
FDA identified the following specific challenges around 3D printing at the PoC:
- Verifying devices 3D printed at PoC are safe and effective
- Assuring appropriate control of devices 3D printed at PoC
- Clarifying the responsible entity
- PoC training and capabilities
FDA Oversight and Regulation
An obvious challenge is that certain 3D printing activities could be considered manufacturing activities, shifting some manufacturing responsibility from traditional medical device manufacturers to the PoC healthcare facility. This paper suggests that healthcare facilities engaging in 3D printing of devices could be asked to meet manufacturer requirements established in 21 CFR, including but not limited to part 807 (registration and listing), part 820 (quality system regulation), part 803 (medical device reporting) and part 806 (reports of corrections and removals).
Following the guidance laid out by the International Medical Device Regulators Forum (IMDRF), FDA is considering a 3D printing medical devices production system (MDPS) to be a device under the Federal Food, Drug, and Cosmetic Act (FD&C Act). An MDPS includes the raw materials, software and digital files, main production and post-processing equipment intended to be used to produce a medical device with a specific purpose. Devices manufactured by the MDPS would still conform to traditional risk and classification based regulatory requirements, which would be used to inform the responsibilities of the healthcare facility engaging in PoC 3D printing.
FDA has presented a few concepts that form their proposed regulatory oversight approach, but as expected, risk management is critical, and risks associated with 3D printing as well as those related to device use should be considered. They also lay out three potential scenarios that could exist between a traditional manufacturer, healthcare facility and the MDPS, and are requesting industry input through specific discussion questions.
The last day to submit comments or feedback is February 8, 2022. Visit https://www.regulations.gov, Docket No. FDA-2021-N-1272, to submit your responses or provide other comments or questions on this discussion paper.
How Can NAMSA Help?
NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with the FDA. In fact, our internal teams of medical device development experts communicate with the FDA nearly every day. From Pre-Submission meetings – to Pre-IDE preparation – and FDA inspection preparation, our teams are the most experienced in industry at accelerating regulatory submissions and approvals for device manufacturers. This expertise has been proven to save medical device organizations up to $17M in costs and 23 months in development timelines.
If you are interested in speaking with us about FDA-related activities or other global regulatory strategies, please contact us at: https://www.namsa.com/contact-us.
Kelly Kucharczyk, RAC
Kelly Kucharczyk, RAC, currently serves as NAMSA’s Associate Director of Global Medical Writing and US Regulatory and Quality Services. Prior to joining NAMSA, Kelly worked in the medical device industry for a decade, leading regulatory teams, developing global marketing access pathways and tackling the regulatory aspects of business development through M&A. She is passionate about helping clients expedite their marketing application timelines through early and on-going development of regulatory strategy, critical assessment of testing and communication with regulators.