This page provides answers to frequently asked questions related to the manufacturing and use of 3D printed swabs.
This section includes questions and answers regarding the policies outlined in the Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff: Policy for Coronavirus Disease-2019 Tests during the Public Health Emergency (Revised). In this section, this guidance is referred to as the Policy for Coronavirus Disease-2019 Tests.
For a directory of FAQs related to SARS-CoV-2 testing, see FAQs on Testing for SARS-CoV-2.
Absorbent tipped applicators (i.e., swabs), whether produced through traditional manufacturing or other means such as additive manufacturing (i.e., 3D printing), are generally Class I medical devices regulated under 21 CFR 880.6025. CDC guidelines recommend that sterile swabs be used for the collection of upper respiratory samples. This is important to preserve both patient safety and specimen integrity. Sterile swabs fall under the product code KXG, whether they are marketed as sterile or intended to be sterilized by the end user. Sterile swabs that are exempt from premarket notification requirements do not need an emergency use authorization (EUA) to be distributed. However, manufacturers are responsible for ensuring their products' performance is appropriate for its intended use. Any facility (including a hospital, laboratory, or other site) that manufactures any swab intended to be used for diagnostic testing must meet applicable medical device regulatory requirements, including Registration and Listing (21 CFR Part 807), medical device reporting (21 CFR Part 803), reports of corrections and removals (21 CFR Part 806), and applicable quality system regulations (21 CFR Part 820). For more information on Registration and Listing, please contact the Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov or see the How to Register and List page.
A: As a general matter, 3D printing can introduce certain challenges not seen with conventional manufacturing. FDA is aware that some users have reported concerns of brittle 3D printed swabs that have broken into multiple sharp pieces, and non-traditional capture geometries that may not capture the sample sufficiently. While FDA and the clinical community have vast experience with traditional swabs, there is limited prior experience with the use of 3D printed swabs for specimen collection for diagnostic testing. Therefore, it is important that 3D printed swabs be assessed to ensure they are appropriately characterized for the end use to determine if they meet the clinical need.
It may be possible to leverage some data provided by the swab designer or other facilities; however, appropriate controls must be in place, and data validation should demonstrate applicability of such data. The Agency is aware that devices produced at different 3D printing facilities can have different characteristics that may affect safety and effectiveness even when using the same printers, resin, and design. Notably, the finishing and sterilization processes, and printer software updates, are among the factors that may have a significant impact on the functionality of 3D printed devices including swabs.
FDA has published a guidance on technical considerations for additive manufactured medical devices, Technical Considerations for Additive Manufactured Medical Devices, and has a webpage on 3D printed devices, accessories, components, and parts relating to the COVID-19 Public Health Emergency Response.
Manufacturers may also wish to consider resources available through the NIH's 3D Print Exchange.
A: Yes. Manufacturers of 3D printed, sterile swabs are required to comply with quality system regulation (21 CFR Part 820).
A: 3D printed swabs are required to meet the general labeling requirements for medical devices. More information on labeling requirements can be found at on the General Device Labeling Requirements page.