Catalog of Regulatory Science Tools to Help Assess New Medical Devices
This regulatory science tool (RST) is a Test Method to easily and efficiently assess the integrity of an additively manufactured (AM) medical device or component that is intended to seal air.
Technical Description
This RST is a leak verification test method for AM components that need to be substantially leak-free, such as face masks and ventilators. Although demonstrated using the open source StopGap revB AM face mask design, the methodology can be adapted for various medical components requiring sealed integrity. This tool allows users to assess the leak integrity of AM components using their own materials and build settings through a pressure decay test. The method can either be used with a defined pressure drop limit or to determine an effective “flaw size” in the component being tested. Pressure drop limits may be established via methods like those described in Ibarra et al. [1]. Representative data were collected using the StopGap revB face mask [1]. Users can leverage this data to verify pressure decay performance.
Intended Purpose
The intended purpose of this RST is to provide a test method with empirical data correlating pressure drop to flaw size, that allows users to perform leak verification testing on their additively manufactured components. These products and components could include product code classifications (procodes) QOZ (Barrier Face Covering), FXX (Mask, Surgical), QKR (Face Mask), OBN (Humidifier, Respiratory, Mask), OXZ (Pediatric/Child Facemask), NMC (Mask, Ventilator), QOS (Continuous Ventilator), QOR (Continuous Ventilator), and MOD (Accessory to Continuous Ventilator). This test method can be used to evaluate the effect of AM build parameters, material selection, and part design on the number/size of flaws that could affect the sealing performance.
Testing
This RST is supported by peer-reviewed published data which investigated the effect of flaw size on pressure drop tests of AM components [1].
Limitations
This RST is limited by the fact that the AM component needs to be modified to integrate with the test fixture. The methods employed for this RST were investigated using air. Additional limitations are discussed in the published manuscript [1].
Supporting Documentation
[1] Ibarra, B., Schwerin, M., Hasani, A. et al. Leak verification method for additively manufactured medical devices. Int J Adv Manuf Technol 140, 1427–1440 (2025). https://doi.org/10.1007/s00170-025-16362-5
Contact
Tool Reference
- RST Reference Number: RST26OP12.01
- Date of Publication: 9/01/2026
- Recommended Citation: U.S. Food and Drug Administration. (2026). Method for Leak Verification of Additively Manufactured Medical Devices Intended to Seal Air (RST26OP12.01). https://cdrh-rst.fda.gov/method-leak-verification-additively-manufactured-medical-devices-intended-seal-air