FDA Clearance Status

Last updated: 2026-09-06

What does "FDA cleared" actually mean?

Most medical software in the U.S. that is regulated by the FDA falls under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Depending on the risk class, a device may need to go through 510(k) premarket notification or Premarket Approval (PMA).

However, the 21st Century Cures Act (2016), Section 3060, carved out an important exemption: certain Clinical Decision Support (CDS) software that meets four criteria is not a regulated medical device under the FD&C Act.

Why our tools fall in the exempt CDS bucket

EyeToolkit calculators meet all four criteria for the CDS exemption:

  1. We do not acquire, process, or analyse medical images or IVD signals. Users enter numeric clinical data (axial length, K-readings, spherical equivalent) by hand.
  2. We display and analyse published medical information. Every formula is from peer-reviewed literature — SRK/T (Retzlaff 1990), Hoffer Q (Hoffer 1993), Haigis, IMI 2021 (Brennan 2020), and the AAO/IMI Amsler protocol.
  3. We support or provide recommendations to a healthcare professional. IOL power outputs, myopia risk classifications, and Amsler abnormality flags are presented for clinical interpretation.
  4. The clinician can independently review the basis for each recommendation. Every output is reproducible by hand from the underlying formula; we expose the calculation inputs and cite the primary references.

Under the FDA 2022 Clinical Decision Support guidance (and the 2026 revision), this combination generally places a tool in the Non-Device CDS category — meaning no 510(k) is required.

What we deliberately avoid

To preserve the CDS exemption we do not claim any of the following anywhere on the site:

  • "FDA approved", "FDA cleared", "FDA authorized", or "registered with the FDA"
  • "Medical grade", "clinically proven accuracy X%", or "diagnostic accuracy Y%"
  • Any number that implies a measured sensitivity or specificity without a peer-reviewed study

The exact code path for ophthalmic diagnostic hardware does exist (for example 21 CFR 886.1150 Visual Acuity Chart, Class I; 21 CFR 886.1330 Amsler Grid). Amsler Grid is literally named in the CFR as a regulated device class. We do not use that classification pathway because our implementation is software-only and the four-factor CDS exemption applies.

Why we are happy not to claim FDA clearance

  • 510(k) clearance for a free, peer-reviewed calculator is a real cost (USD 30k+ in fees, plus a Quality System under 21 CFR Part 820) that would not be recouped.
  • Submitting to the FDA would also lock the formulas at the time of clearance, slowing our ability to update for new evidence (for example an updated IMI myopia report).
  • Most importantly: claiming FDA clearance would not actually make the tools more clinically useful. The formulas are the same.

What we do instead

  • Every formula is cited inline, with links to the primary literature.
  • Every page carries a clear medical disclaimer: these are educational aids, not medical advice, diagnosis, or treatment.
  • All three tools tell the user — in clinical warning style — when to seek a licensed professional (for example Amsler flag → consult an ophthalmologist promptly).

References

  • 21st Century Cures Act, Section 3060 (2016).
  • FDA, Clinical Decision Support Software — Guidance for Industry and FDA Staff, 28 Sep 2022 (87 FR 58810).
  • 21 CFR Part 886 — Ophthalmic Devices (including § 886.1150 Visual Acuity Chart, § 886.1330 Amsler Grid).
  • 21 CFR Part 820 — Quality System Regulation.

Effective date: 2026-09-20