FDA-Approved Non-Invasive Glucose Meter: What Exists?

Is there an FDA-approved non-invasive glucose meter?

In its safety communication dated 21 February 2024, the FDA stated that it has not authorized, cleared or approved any smartwatch or smart ring intended to measure or estimate blood glucose on its own. The same communication warns people not to use smartwatches or smart rings that claim to measure blood glucose without piercing the skin, whatever the brand. That is the answer to the search as of that dated statement; the FDA page is the place to look for anything issued later.

Who this is for: clinic staff, buyers and caregivers who have seen a “needle-free” or “no finger prick” glucose claim and need to tell an authorized device from an unreviewed one. After reading, you should be able to name the device category a claim belongs to, say what the FDA has stated about it, and know which record to ask for.

What FDA-authorized glucose meters actually measure

The FDA describes a blood glucose monitoring device as a handheld meter plus test strips that uses a small blood sample. A lancet pricks the finger, the strip reacts with glucose in the blood, and the meter reads the result electrically or by light. Our guide to the glucometer covers the parts in more detail.

The FDA page lists the palm, upper arm, forearm, thigh and calf as sites some meters allow, and states that results from an alternative sampling site are never used to calibrate a continuous glucose monitor (CGM).

Types and variants: claim versus what the FDA says

Category	How it samples	What the FDA says (source and date)
Fingerstick blood glucose meter with test strips	Small blood sample from a lancet prick, read from a test strip	Described as a blood glucose monitoring device on the FDA page (checked 3 November 2026). In the FDA device classification database, glucose test systems fall under 21 CFR 862.1345, class 2, including the over-the-counter product code NBW (checked 3 November 2026).
Continuous glucose monitor (CGM)	Sensor worn on the body; the 2024 FDA communication treats these as skin-piercing devices	Integrated CGM systems are listed under 21 CFR 862.1355, class 2, with product codes such as QBJ (checked 3 November 2026 in the FDA classification database). The communication separates watch apps that only display data from an authorized CGM from watches that claim to measure glucose themselves.
Smartwatch or smart ring claiming to measure glucose without piercing the skin	Claimed sensing without a blood sample	FDA safety communication, 21 February 2024: not authorized, cleared or approved for measuring or estimating blood glucose on its own; the FDA has not reviewed its safety or effectiveness.

See CGM accuracy for how sensor readings are evaluated, and what counts as a medical device for the regulatory definition.

Why smartwatch and ring claims matter

The FDA named a specific risk: inaccurate readings could lead someone to take the wrong dose of insulin or other diabetes medication, with dangerously low blood sugar as a possible result. The communication advises consumers and caregivers against using these products and points them to a health care provider for questions about FDA-authorized devices. It asks providers to discuss the risks with patients. Our guide to FDA safety communications explains how to read this type of notice.

How to verify a glucose-device claim

These checks use only what the FDA sources above state or show.

• Sort the claim into a category from the table. A device that reads glucose without any skin piercing, worn on a wrist or finger, falls in the category the FDA’s 2024 communication addresses.
• Ask the seller which FDA authorization applies to the exact product, and for the product code or regulation number. Authorized glucose systems appear in FDA records under the regulations and product codes shown above.
• Check whether the product measures glucose or only displays data from an authorized device. The FDA treats those as different categories.
• Check the FDA safety communications page for anything issued after 21 February 2024 before relying on this page’s date.

Safe use basics

General points from the FDA pages: the FDA states that alternative-site results are never used to calibrate a CGM, and for a device’s intended use the product labelling governs. Problems with a glucose device can be reported to the FDA through MedWatch. Our glucose meter recall guide covers how to check whether a meter has been recalled. Clinics and labs that stock testing supplies can browse diagnostic, monitoring and imaging supplies.

Common mistakes

• Treating a watch that displays CGM data as if it measured glucose itself. The FDA separates the two.
• Assuming that a product sold online has been reviewed by the FDA. The FDA stated it has not reviewed the safety or effectiveness of these smartwatches and rings.

FAQ

Is there an FDA-approved non-invasive glucose meter?

The FDA’s 21 February 2024 communication states it has not authorized, cleared or approved any smartwatch or smart ring intended to measure or estimate blood glucose on its own. Check the FDA page for later updates.

Do CGMs count as non-invasive?

The FDA communication describes CGMs as skin-piercing devices. They are a different category from a watch or ring that claims to need no skin piercing.

Can a smartwatch show glucose from an authorized device?

Yes. The FDA distinguishes watch apps that display data from an FDA-authorized skin-piercing device such as a CGM from watches that claim to measure glucose themselves.

Where can I report a problem?

The FDA directs people to report problems with these devices through MedWatch.

Sources

• FDA, Do Not Use Smartwatches or Smart Rings to Measure Blood Glucose Levels: FDA Safety Communication, issued 21 February 2024, checked 3 November 2026.
• FDA, Blood Glucose Monitoring Devices, checked 3 November 2026.
• FDA, device classification database (openFDA), regulations 21 CFR 862.1345 and 862.1355, api.fda.gov/device/classification, checked 3 November 2026.