Built for the “does this count?” moment.
DeviceOrNot is operated by Kareem Altal, based in the United States. This tool supports early exploration by health-software builders; it is not a regulator or certification body.
DeviceOrNot helps health-software builders organize their intended purpose, functions and claims before talking to a regulatory expert. Each software function is evaluated separately against editable, versioned JSON rules. A pure deterministic engine decides every outcome; AI can only assist with drafting and explanation. The adapted qualification rules are owner-approved for restricted manual testing, with provisional results. Regulatory sign-off remains pending and the separate classification rules remain DRAFT. Official sources are linked below; inclusion does not imply endorsement or an approved interpretation.
- FDA Digital Health Policy Navigator
- FDA Clinical Decision Support Software Final Guidance (Jan 2026)
- FDA General Wellness: Policy for Low Risk Devices (Jan 2026)
- FDA Medical Device Data Systems (MDDS) Guidance
- EU MDCG 2019-11 rev. 1: Qualification and Classification of Software (June 2025)
- UK Medical Devices Regulations 2002 (SI 2002/618, as amended)
- MHRA Software and AI as a Medical Device Guidance