Description
FDA is issuing this guidance to provide industry and agency staff with recommendations for studies to establish the analytical and clinical performance of highly multiplexed microbiological/medical countermeasure in vitro nucleic acid based diagnostic devices (hereafter referred to as HMMDs) intended to simultaneously detect and identify multiple pathogen nucleic acids extracted from a single appropriate human specimen or culture. For the purposes of this guidance document, the multiplex level that is used to define HMMDs is the capability to detect ≥20 different organisms/targets, in a single reaction, using a nucleic acid-based technology and involves testing multiple targets through a common process of specimen preparation, amplification and/or detection, and result interpretation. HMMDs are used to aid in the diagnosis of infection or screening for colonization. This guidance is not intended to replace or supersede other assay specific guidance documents.
Scope & Applicability
Product Classes
7The primary subject of the guidance, defined as HMMDs.; Subject of the guidance document; The subject of the guidance document.; Subject of the guidance document regarding clinical evaluation and post-market analysis.
perform an evaluation of the cleared device (i.e., device without new analyte) and the modified version.
Abbreviation for Highly Multiplexed Microbiological Diagnostic devices.
tests that have an underlying numerical output or estimate overall variance
Human cells, tissues, or cellular or tissue-based products defined in 21 CFR Part 1271
FDA provides recommendations for data submission for these devices
Class III subject to the 510(k) or PMA requirements
Stakeholders
2Entity responsible for submitting NDINs
Entity responsible for submitting applications under section 524B
Regulatory Context
Attributes
8Evidence of a new intended use based on communications
Present results as a mean and associated 95% two-sided CI
Clinical performance metric requiring a minimum of 50 positive specimens per organism.
Clinical performance metric evaluated using prospectively collected specimens.
Acceptable quality for generated sequences as measured by PHRED.
In vitro diagnostic devices of this type are typically considered a moderate level of concern
The value used to distinguish positive from negative results.
Values defining positive, negative, or invalid results
Identified Hazards
Hazards
6Risk associated with construction, traffic flow, and shared equipment.; Risk from raw food to RTE food or from insanitary objects; Personnel handling RTE foods touch contaminated surfaces
Evaluation of competitive interference and interference from other microbes should be done for the new analyte.
Potential for the assay to react with non-target pathogens.; Evaluation of cross-reactivity should be done for the new analyte based on section 6.B.iii.
Endogenous and exogenous interference studies
Risk leading to unnecessary treatment for acute radiation syndrome.
Risk leading to failure to provide lethal-prevention treatment.
Related CFR Sections (3)
- 21CFR862.2570§ 862.2570 Instrumentation for clinical multiplex test systems.
(a) Identification. Instrumentation for clinical multiplex test systems is a device intended to measure and sort multiple signals generated by an assay from a clinical sample. This instrumentation is used with a specific assay to measure multiple similar analytes that establish a single indicator toRead 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 →
- 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 →
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)
- 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review: Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations (Status: Final)
- Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
- Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Display Devices for Diagnostic Radiology: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Intravascular Administration Sets Premarket Notification Submissions [510(k)]: Guidance for Industry and FDA Staff (Status: Final)
- Hemodialysis Blood Tubing Sets - Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff (Status: Final)
- Dental Handpieces - Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff (Status: Final)
- Keratome and Replacement Keratome Blades Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff (Status: Final)