Description
In 2003, FDA issued an updated guidance on the "Replacement Reagent and Instrument Family Policy" for in vitro diagnostic (IVD) devices. The 2003 guidance described a mechanism for manufacturers to follow when applying an assay that was previously cleared based on performance characteristics when used with a specified instrument to an additional instrument that is either cleared or a member of an instrument family from which another instrument was previously cleared. Through the approach described in the 2003 guidance, manufacturers established sufficient control to maintain the level of safety and effectiveness demonstrated for the cleared device for these types of modified devices, when evaluated against predefined acceptance criteria using a proper validation protocol, without submission of a premarket notification (510(k)).
Scope & Applicability
Product Classes
7Validation of certain in vitro diagnostic devices (IVDs) for emerging pathogens; Validation of certain IVD devices for emerging pathogens
Proposed classification for NGS-based tests for germline diseases.
Point-of-care systems with specific environmental and use-error risks
Pertains to IVD test systems regulated by CDRH; In vitro diagnostic test systems intended for use in CLIA-regulated laboratories
Subject to General Controls and Premarket Approval
Devices excluded from certain policy applications
Assay/instrument systems considered combination devices
Stakeholders
2Entity responsible for submitting NDINs
Entity responsible for assessing capabilities and performance of the new combination; Entity responsible for verifying and validating the modified test system
Regulatory Context
Attributes
3Level demonstrated for the cleared device; Core regulatory standard for assay performance
Clinical performance parameter that may require assessment for modifications
Instrument with general purpose features for use with wide array of assay types
Identified Hazards
Hazards
2Risk 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
Potential safety concerns identified during assessment
Related CFR Sections (3)
- 21CFR807.81§ 807.81 When a premarket notification submission is required.
(a) Except as provided in paragraph (b) of this section, each person who is required to register his establishment pursuant to § 807.20 must submit a premarket notification submission to the Food and Drug Administration at least 90 days before he proposes to begin the introduction or delivery for inRead full regulation →
- 21CFR866.5775§ 866.5775 Rheumatoid factor immunological test system.
(a) Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diaRead full regulation →
- 21CFR860.3§ 860.3 Definitions.
For the purposes of this part: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)
- Deciding When to Submit a 510(k) for a Change to an Existing Device: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted under a BLA, NDA or ANDA: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
- Predetermined Change Control Plans for Medical Devices: Draft Guidance for Industry and FDA Staff (Status: Draft)
- 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)
- Suggested Format For IDE Progress Report (Status: Final)
- Design Control Guidance For Medical Device Manufacturers: Guidance for Industry (Status: Final)
- Quality System Information for Certain Premarket Application Reviews : Guidance for Industry and FDA Staff (Status: Final)
- Marketing Clearance of Diagnostic Ultrasound Systems and Transducers : Guidance for Industry and Food and Drug Administration Staff (Status: Final)