| Gene | Category | Predicted log2FC | Direction | Gap Detected |
|---|
Analyze receptor occupancy and pathway modifications from concurrent medications.
Propagate parameter uncertainty through the model to quantify output variability.
Global variance-based sensitivity indices identifying key model parameters.
Spatial zone decomposition of endometrial tissue compartments and pathway scores.
Simulate follicular growth, predict oocyte yield, assess OHSS risk, and compare stimulation protocols using POSEIDON stratification.
Section 3060(a) of the 21st Century Cures Act (Pub. L. 114-255, enacted December 13, 2016) amended Section 520 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j) to add subsection (o), which excludes certain clinical decision support software from the definition of a "device" under Section 201(h) of the FD&C Act. Software meeting all four criteria of Section 520(o)(1)(E) is not a medical device and requires no FDA clearance, approval, or registration.
FDA guidance: "Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act" (January 2026, superseding September 2022 version). Available at: FDA.gov Guidance Documents.
| # | Statutory Criterion | EndoTwin-W (prior internal assessment) | Met? |
|---|---|---|---|
| 1 | Not intended to acquire, process, or analyze a medical image, a signal from an in vitro diagnostic device, or a pattern or signal from a signal acquisition system. | EndoTwin-W accepts numerical laboratory values (glycodelin-A and CA-125 concentrations) manually entered from a standard blood draw report. It does not process medical images, raw IVD instrument signals, or signal acquisition patterns. | Yes |
| 2 | Intended for the purpose of displaying, analyzing, or printing medical information about a patient or other medical information. | EndoTwin-W analyzes and displays patient-specific medical information: Progesterone Resistance Score, pathway disruption profiles, predicted gene expression changes, biomarker assessment, and window-of-implantation timing predictions. | Yes |
| 3 | Intended for the purpose of supporting or providing recommendations to a health care professional about prevention, diagnosis, or treatment of a disease or condition. | EndoTwin-W provides recommendations to OB/GYN physicians regarding endometrial receptivity assessment, progesterone resistance classification, and condition-specific pathway disruptions as a research aid for studying endometrial receptivity. | Yes |
| 4 | Intended for the purpose of enabling such health care professional to independently review the basis for such recommendations so that it is not the intent that the professional rely primarily on any of such recommendations to make a clinical decision regarding an individual patient. | EndoTwin-W displays full mechanistic transparency: individual pathway disruption scores, per-gene predicted expression changes with fold-change magnitudes, underlying biomarker values, radar visualization of pathway contributions, and gap detection analysis. The clinician can independently evaluate the basis for every recommendation and is expected to exercise independent clinical judgment. | Yes |
References: 21st Century Cures Act, Pub. L. 114-255, Section 3060(a) (2016); 21 U.S.C. 360j(o)(1)(E); FDA Guidance, "Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act" (January 2026).