Regulatory Science Tools Catalog
The Regulatory Science Tools Catalog provides a peer-reviewed resource for use where standards and qualified Medical Device Development Tools (MDDTs) do not yet exist. These tools do not replace FDA-recognized standards or MDDTs. This catalog collates a variety of regulatory science tools that the FDA's Center for Devices and Radiological Health's (CDRH) Office of Science and Engineering Labs (OSEL) developed. If you are considering using a tool from this catalog in your marketing submissions, note that these tools have not been qualified as Medical Device Development Tools and the FDA has not evaluated the suitability of these tools within any specific context of use. You may request feedback or meetings for medical device submissions as part of the Q-Submission Program.
This regulatory science tool presents an apparatus to measure transfer functions (TF) of implantable medical devices in curved trajectories for MRI safety assessment.
This regulatory science tool describes a method which can be utilized in the Magnetic Resonance Imaging (MRI) safety assessment of implantable medical devices to assist in the prediction of potential RF-induced heating in the human body (or induced voltage in the device) in clinical 1.5T and 3T MRI scanners.
This regulatory science tool is a method that models the link-level traffic patterns in medical extended reality (MXR) applications, which is intended to help recognize application-specific data transmission requirements in IP-based connected medical devices.
This regulatory science tool is a lab method for building a 5G network testbed to assess data transmission of medical device functions using 5G connectivity.
A statistical approach for estimating the likelihood of wireless coexistence of a medical device in its intended environment based on experimental evaluation and realistic environment measurements