Description
FDA has developedthis guidanceto provide industry and Agency staff with recommendations for the types of information that should be submitted to support marketing authorization (e.g., clearance or approval) for radiation biodosimetry medical countermeasure devices (referred to as “biodosimetry devices” or “biodosimeters” throughout this document). This guidance applies to premarket submissions for medical device systems intended to measure biological responses to unintended (non-therapeutic) radiation absorption. Biodosimetry devices are devices used for the purpose of reconstructing the ionizing radiation dose received by individuals or populations using physiological, chemical, or biological markers of exposure found in humans. Biodosimetry technologies may be used at various stages during triage, including both early mass casualty triage and subsequent clinical evaluation. Such exposures could be the result of intentional harm or as a consequence of a disaster. Devices may be designed to give quantitative outputs or qualitative information around a clinical decision making cut-point. Likewise, devices may be designed for use in field triage settings, at patient bedsides, or in Clinical Laboratory Improvement Amendments of 1988 (CLIA) certified clinical laboratories. FDA considered both high-throughput and single-use devices in developing this guidance document.
Scope & Applicability
Product Classes
4Subject of the guidance document; Subject of the guidance document for assessing radiation absorption.; Subject of the guidance document regarding analytical and clinical validation.; The guidance applies to these specific devices for measuring radiation absorption.
IVDs for emerging pathogens during a Section 564 declared emergency
Medical countermeasure devices used to assess radiation exposure; Guidance for developing labeling and performance characteristics for radiation biodosimetry medical countermeasure devices.
IVDs mentioned regarding clinical decision-making impact
Stakeholders
4Entity responsible for submitting applications under section 524B
Intended users for whom labeling must be written in understandable terms.
Requires approval and oversight of applicable animal research
Entity responsible for submitting NDINs
Regulatory Context
Attributes
10General consideration for submission contents
A component of precision validation; Repeatability should be assessed using a minimum of nine determinations; Precision under the same operating conditions over a short interval of time.
Systematic errors introduced due to sampling or measurement.
A global measure of device discrimination performance.
One of the three levels of CLIA test complexity.
One of the three levels of CLIA test complexity.
One of the three levels of CLIA test complexity.
Stability of the substance being detected in archived specimens
Determines the information to be submitted based on risks associated with software failure.
Performance characteristic assessed via linearity experiment
Identified Hazards
Hazards
4The event the device is intended to measure
The spectrum of radiation absorption resulting from accidental exposures.
Risk leading to unnecessary treatment for acute radiation syndrome.
Risk leading to failure to provide lethal-prevention treatment.
Related CFR Sections (4)
- 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 →
- 21CFR812.119§ 812.119 Disqualification of a clinical investigator.
(a) If FDA has information indicating that an investigator (including a sponsor-investigator) has repeatedly or deliberately failed to comply with the requirements of this part, part 50 , or part 56 of this chapter , or has repeatedly or deliberately submitted to FDA or to the sponsor false informatRead full regulation →
- 21CFR812.2§ 812.2 Applicability.
(a) General. This part applies to all clinical investigations of devices to determine safety and effectiveness, except as provided in paragraph (c) of this section.Read full regulation →
- 21CFR809.3§ 809.3 Definitions.
(a) In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use Read full regulation →
Related Warning Letters (10)
- 2025-08-26
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
CCIC Huatongwei International Inspection Co., Ltd.
- 2025-08-26
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Jiangsu Kerbio Medical Technology Group Co.
- 2024-09-11
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Mid-Link Testing Company, Ltd
- 2024-09-11
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Sanitation & Environmental Technology Institute dba SDWH
- 2023-11-14
CGMP/QSR/Medical Devices/Misbranded
Wello Inc.
- 2023-10-31
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Samm Solutions, Inc., d.b.a. BTS Research
- 2022-08-09
Bioresearch Monitoring Program
Valley Biosystems
- 2022-02-22
Good Laboratory Practice (GLP)
Toxikon Corporation/Labcorp Bedford LLC
- 2020-05-05
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
University of Kentucky
- 2020-04-07
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Steiner Biotechnology, LLC
See Also (8)
- Administrative Procedures for CLIA Categorization: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments (Status: Final)
- Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203) (Status: Final)
- Shelf Life of Medical Devices (Status: Final)
- Pharmacogenetic Tests and Genetic Tests for Heritable Markers: Guidance for Industry and FDA Staff (Status: Final)
- Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle: Draft Guidance for Industry, Food and Drug Administration Staff, and Other Interested Parties (Status: Draft)