Description
This guidance document describes studies and information that FDA recommends be used when submitting premarket notifications (510(k)s) for self-monitoring blood glucose test systems (SMBGs) which are for over-the-counter (OTC) home use by lay-users.1This guidance document is intended to guide manufacturers in conducting appropriate performance studies and preparing 510(k) submissions for these device types and replaces the final guidance entitled "Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use" issued on October 11, 2016.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
2Devices intended for over-the-counter home use by lay-users.; Guidance for industry and FDA staff regarding OTC use; Devices intended for over-the-counter use to monitor blood glucose.; Guidance for over-the-counter use of blood glucose test systems.; The device type being evaluated for interference and robustness.; The guidance applies to SMBG systems for over-the-counter use.; Guidance for over-the-counter use systems
Intended for use by healthcare professionals
Stakeholders
3non-professional users of pulse oximeters
manufacturers other than the meter manufacturer
Individuals with wide ranges in age and dexterity using SMBGs at home; The intended user population of SMBGs is the lay-user.; Intended user population for OTC SMBG; instructions to contact healthcare provider
Regulatory Context
Regulatory Activities
3Premarket notification submission type
FDA recommends you submit a Special 510(k)
Submission including device performance data and biocompatibility conclusions
Document Types
5Cybersecurity information should be included in device labeling
Labeling information including dosage, administration, and safety sections
Readability assessment should be performed on the control solution insert.; Package insert for controls
Readability assessment should be performed on the test strip insert.; Package insert for test strips
Documentation accompanying electronic products that can be provided in paper or electronic form
Attributes
9Former risk classification for CADe devices under the superseded guidance.; Typical risk classification for CADe software
Factor influencing the effectiveness of cleaning and sanitizing agents.
Open vial stability mimics conditions where the vial is opened and closed.
Information recommended for inclusion in the notification
A physiological property that can contribute to analytical error in glucose monitoring.; High altitude can result in changes to hematocrit.
The entire claimed measuring range of the device.
Level of documentation required based on risk; documentation threshold for software functions; Risk-based documentation category; Outcome for software functions with low risk of death or serious injury
Imprecision under conditions of repeated measurement of the same sample.
Imprecision under simulated normal use conditions over multiple days.
Technical Details
Substances
10Substance/factor evaluated during interference testing.
SMBGs should report results in terms of plasma equivalents
Used for accuracy and precision evaluations.
Used in precision studies over 5 days.
Antioxidant used to inhibit NDSRI formation; antioxidant used to inhibit nitrosamine formation
Known or potential interferent for blood glucose measurement.; Listed as an example interferent in the recommended summary table format.
Not effective against viral bloodborne pathogens
May lead to physical degradation of the device
Composition and levels of material used to verify system performance.; External control solutions used to check system performance.
Sample type used for within-run precision and linearity studies.
Testing Methods
10Performance evaluation study recommended for SMBGs.
sampling from anatomical sites other than the fingertip
Used for periodic technique review and comparison
Performed using whole blood samples spanning the claimed measuring range.
Demonstrates precision calculated is within labeled performance.
Suitable analysis procedure for calculating confidence intervals.
Plotting the results and using the slope to represent beta results in the following graphs.
Recommended computer program to assess the readability grade level of the labeling.
Recommended computer program to assess the readability grade level of the labeling.
Performance evaluation study recommended for SMBGs.
Processes
10Study to assess system accuracy in the hands of intended users.
Procedures that must be validated to reduce bloodborne pathogen transmission.; Validated procedures required to prevent disease transmission between patients.
Labeling must provide instructions for collection and preparation
Occurs when a user adds more sample before measurement is complete.
Demonstrates how SMBG handles events like wicking blood away.
System should detect reduced blood volume to avoid inaccurate results.
Studies on the effects of altitude on SMBG device performance.
Assesses performance under various temperature and humidity conditions.
Studies assessing performance throughout stability claims.
A type of flex study recommended for SMBG systems.
Clinical Concepts
8Infection requiring medical data collection in pregnancy
patients with type 2 diabetes may face unique safety issues such as a risk for hypoglycemia
Intended use for people with diabetes
Expected toxicity with many MDS drugs
Conditions known to interfere with glucose monitoring should be included in labeling.
Hematocrit values should be determined and recorded for each study participant.
The pathogen (HBV) being screened in blood donations.
Low blood glucose readings range where ISO 15197 is considered insufficient.
Identified Hazards
Hazards
1Safety risk addressed through cleaning and disinfection validation.; Risk that device features should be designed to minimize.; Risk from use of device on multiple patients; risk of disease transmission when using SMBGs
Standards & References
External Standards
5Risk Management Techniques to Identify and Control Laboratory Error Sources
Labeling of Home-Use In Vitro Testing Products
Standard Test Method for Efficacy of Virucidal Agents
Standard Practice for Evaluation of Pre-saturated Towelettes
Evaluation of the Linearity of Quantitative Measurement Procedures.
Specifications
8Includes response time, settling time, and steady state-deviation; Criteria for sensors, actuators, and algorithms
Labeling should indicate display when glucose is outside range
Minimum altitude for testing SMBG effects.
Statistical requirement for reporting interference testing results.
SMBGs should minimally be able to measure blood glucose accurately between 50 mg/dL and 400 mg/dL.
99% of all SMBG results are within +/- 20% of the comparator results.
95% of all SMBG results in this study are within +/- 15% of the comparator results.
For a product intended for home use, the reading level should be at an 8th grade level or less.
Related CFR Sections (3)
- 21CFR809.10§ 809.10 Labeling for in vitro diagnostic products.
(a) The label for an in vitro diagnostic product shall state the following information, except where such information is not applicable, or as otherwise specified in a standard for a particular product class or as provided in paragraph (e) of this section. Section 201(k) of the act provides that “a Read full regulation →
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read full regulation →
- 21CFR862.1345§ 862.1345 Glucose test system.
(a) Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglRead full regulation →
Enforcement Impact
Deficiencies cited in Warning Letters referencing the same regulations
Recent Cases
- 2026-02-24
CGMP/QSR/Medical Devices/Adulterated
Beta Bionics, Inc.
- 2025-12-09
CGMP/QSR/Medical Devices/Adulterated
Envoy Medical Inc.
- 2025-11-25
CGMP/QSR/Medical Devices/Adulterated
Hong Qiangxing Shenzhen Electronics Limited
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated
Contec Medical Systems Co., Ltd.
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Royal Philips
Related Warning Letters (10)
- 2026-02-24
CGMP/QSR/Medical Devices/Adulterated
Beta Bionics, Inc.
- 2025-12-09
CGMP/QSR/Medical Devices/Adulterated
Envoy Medical Inc.
- 2025-11-25
CGMP/QSR/Medical Devices/Adulterated
Hong Qiangxing Shenzhen Electronics Limited
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated
Contec Medical Systems Co., Ltd.
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Royal Philips
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Qianjiang Kingphar Medical Material Co Ltd.
- 2025-10-21
CGMP/QSR/Medical Devices/Adulterated
LEVO AG
- 2025-10-07
CGMP/QSR/Medical Devices/Adulterated
Technological Medical Advancements LLC
- 2025-09-23
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
The Richline Group, Inc.
- 2025-09-16
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
SeniorLife Technologies, Inc.
Related MFDS Guidelines
Korean regulatory guidelines covering similar topics
See Also (8)
- Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- CPG Sec. 130.400 Use of Microfiche and/or Microfilm for Method of Records Retention (Status: Final)
- CPG Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections (Status: Final)
- CPG Sec. 300.100 Inspection of Manufacturers of Device Components (Status: Final)
- Device Labeling Guidance #G91-1 (Blue Book Memo) (Status: Final)
- CPG Sec. 310.100 Pacemaker Reuse (Status: Final)
- Variance from Manufacturer Report Number Format - No. 5 (Status: Final)
- Immunotoxicity Testing Guidance (Status: Final)