# Federal Register 2026-18612 — effective 2026-09-11 — Medical Devices; Cardiovascular Devices; Classification of the Cardiovascular Machine Learning-Based Notification Software — Food and Drug Administration

For Federal Register 2026-18612, effective date is 2026-09-11; agency is Food and Drug Administration; published is 2026-09-11; cfr parts amended is 21 CFR 870, recorded from its source on 2026-09-14; source re-checked 2026-09-16.

- **FR document number:** 2026-18612 _(verified: appears in the quote below)_
- **Rule:** Medical Devices; Cardiovascular Devices; Classification of the Cardiovascular Machine Learning-Based Notification Software _(verified: appears in the quote below)_
- **Agency:** Food and Drug Administration _(verified: appears in the quote below)_
- **Effective date:** 2026-09-11 _(verified: appears in the quote below)_
- **DATES, as printed:** This order is effective September 11, 2026. The classification was applicable on August 3, 2023. _(verified: appears in the quote below)_
- **CFR parts amended:** 21 CFR 870 _(our reading, not quoted from the source)_
- **Published:** 2026-09-11 _(verified: appears in the quote below)_

## What the source says

> {"document_number":"2026-18612","title":"Medical Devices; Cardiovascular Devices; Classification of the Cardiovascular Machine Learning-Based Notification Software","agency_names":["Health and Human Services Department","Food and Drug Administration"],"effective_on":"2026-09-11","dates":"This order is effective September 11, 2026. The classification was applicable on August 3, 2023.","cfr_references":[{"chapter":null,"citation_url":null,"part":"870","title":21}],"publication_date":"2026-09-11","html_url":"https://www.federalregister.gov/documents/2026/09/11/2026-18612/medical-devices-cardiovascular-devices-classification-of-the-cardiovascular-machine-learning-based"}

## Source

- https://www.federalregister.gov/api/v1/documents.json?per_page=1000&order=oldest&conditions%5Btype%5D%5B%5D=RULE&conditions%5Beffective_date%5D%5Bgte%5D=2026-08-31&conditions%5Beffective_date%5D%5Blte%5D=2026-12-31&fields%5B%5D=document_number&fields%5B%5D=title&fields%5B%5D=agency_names&fields%5B%5D=effective_on&fields%5B%5D=dates&fields%5B%5D=cfr_references&fields%5B%5D=publication_date&fields%5B%5D=html_url

Last verified: 2026-09-16. Review by: 2026-09-29.
Part of [Federal rules taking effect: every US final rule in the Federal Register, by effective date](https://referencesource.org/federal-rules-taking-effect/).