Description
This guidance document describes studies and information that FDA recommends be used when submitting premarket notifications (510(k)s) for blood glucose monitoring systems (BGMSs) which are for prescription point-of-care use. This 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 "Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use" issued on October 11, 2016.
Scope & Applicability
Product Classes
4The primary device type addressed in this guidance, categorized under a Basic Documentation Level.
Abbreviated as CGMS; labeling should state alternative site results should not be used to calibrate these.
Devices for OTC home use, excluded from the scope of this guidance.; Devices intended for home use by lay-users.
Devices intended for prescription point-of-care use.; Prescription point-of-care use device subject to this guidance; Guidance for prescription point-of-care use devices; Each sample should be tested on your new BGMS; Guidance for prescription point-of-care use systems; Subject of the guidance document regarding prescription point-of-care use.; The type of device being discussed for submission eligibility.
Stakeholders
8Assist sponsors in the nonclinical evaluation
Entity responsible for submitting NDINs
Entity responsible for submitting applications under section 524B
manufacturers other than the meter manufacturer
Samples should be collected and measured by at least three POC users
Subjects less than 28 days old
Point-of-care users such as nurses or nurse assistants
Intended users in professional settings.; Users who must adhere to standard precautions.
Regulatory Context
Attributes
9Level 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
Defined limits for accuracy that samples must meet.
Reporting format for BGMS results in the U.S.
Determined by the sponsor for the investigational product.; investigational product(s) are stable over the period of use and only used within the current shelf life
neonatal blood often has higher hematocrit levels (51 to 65%); Each sample should be tested on your new BGMS in replicates of 30
10 mg/dL to 500 mg/dL for hospital settings
Measured in mg/dL and reported in plasma equivalents
Former risk classification for CADe devices under the superseded guidance.; Typical risk classification for CADe software
Risk-based approach to determine information amount for premarket submission
Identified Hazards
Hazards
2Safety 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
reuse of insulin pens on multiple patients can result in exposure to bloodborne pathogens
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 →
Related Warning Letters (10)
- 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.
- 2025-08-26
CGMP/QSR/Medical Devices/Adulterated
Miach Orthopaedics
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)