Description
FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases and public health emergencies. This draft guidance describes general recommendations for the validation of in vitro diagnostic devices (IVDs) for emerging pathogens during an applicable declaration under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). These recommendations apply to test data and information submitted in a pre-Emergency Use Authorization (EUA), an EUA request, or to a test offered under an applicable enforcement discretion policy. Ageneric templateis also being made available through download from FDA’s website, which reflects FDA’s current thinking on validation study recommendations.
Scope & Applicability
Product Classes
8Validation of certain in vitro diagnostic devices (IVDs) for emerging pathogens; Validation of certain IVD devices for emerging pathogens
Tests performed and interpreted by individuals in non-laboratory settings.
Tests that can detect and differentiate between pathogens causing multiple diseases with similar symptoms.
FDA has observed significant cross-reactivity with different brands and types of VTM
Inclusivity of antigen-based tests should be evaluated through wet testing
Specific test type considered in the guidance; Kits for home collection of clinical specimens to increase patient access.
Specific test type considered in the guidance; Tests intended for use in near-patient settings like hospitals or urgent care.
IVDs for emerging pathogens during a Section 564 declared emergency
Stakeholders
4Entity responsible for conducting validation studies
Untrained individual performing home collection or home testing.
Participants in usability and user comprehension studies
Governs top dose in clinical studies
Regulatory Context
Attributes
5Protection of software and device data
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
The stability of specimens collected and stored should be evaluated in real-world conditions
The LoD provides a measure of the analytical sensitivity
Method used to evaluate the performance of the new test
Identified Hazards
Hazards
5Pathogens triggering a Section 564 declared emergency
Components of collection kits should be assessed for toxicological risk.
Risk of device functionality being compromised
automated liquid handling systems can pose a risk of contamination within or between test runs
The high-dose hook effect, where false negative results occur due to the presence of very high levels of the target analyte
Related CFR Sections (2)
- 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 →
- 21CFR50.22§ 50.22 Exception from informed consent requirements for minimal risk clinical investigations.
The IRB responsible for the review, approval, and continuing review of the clinical investigation described in this section may approve an informed consent procedure that does not include or that alters some or all of the elements of informed consent set forth in § 50.25(a) and (b) , or may waive thRead 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
- 2025-09-09
Clinical Investigator
Shirish M. Gadgeel, M.D.
- 2025-08-12
CGMP/QSR/Medical Devices/Adulterated
Spectra Therapy, LLC
- 2025-08-05
CGMP/QSR/Medical Devices/Adulterated
Mectronic Medicale S.R.L.
- 2025-07-15
Clinical Investigator
Mark J. Savant, M.D
- 2025-06-24
CGMP/QSR/Medical Devices/Adulterated
Aju Pharm Co., Ltd.
- 2025-05-27
CGMP/QSR/Medical Devices/Adulterated
Sedecal S.A.
- 2025-05-20
CGMP/QSR/Medical Devices/Adulterated
NeuroSync, Inc.
- 2025-05-20
Bioresearch Monitoring Program/Institutional Review Board (IRB)
United Health Products, Inc.
See Also (8)
- Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- CPG Sec. 300.600 Commercial Distribution with Regard to Premarket Notification (Section 510(k)) (Status: Final)
- CPG Sec. 350.100 Packaging Technologies and Tamper-Resistant Packaging Requirements for Contact Lens Solutions and Tablets (Status: Final)
- CPG Sec. 310.100 Pacemaker Reuse (Status: Final)
- Hysteroscopic and Laparoscopic Insufflators: Submission Guidance for a 510(k) (Status: Final)
- Kit Certification for 510(k)s (Status: Final)
- Immunotoxicity Testing Guidance (Status: Final)
- Inspection and Field Testing of Radiation-Emitting Electronic Products: Attachment C: Specific Instructions for Sunlamp Product Inspections and Tests (Status: Final)