# Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices:  Guidance for Industry and FDA Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/replacement-reagent-and-instrument-family-policy-for-in-vitro-diagnostic-devices-guidance-for-industry-and-fda-staff/6acf5cea-4730-4835-bf2d-eb7474c6d3e6

> FDA guidance document: Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices:  Guidance for Industry and FDA Staff. Issue date: August 17, 2022. Get complete insights and analysis.

---

## Details

- Title: Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices:  Guidance for Industry and FDA Staff
- Communication Type: Guidance Document
- Product Type: devices
- Office Name: Center for Devices and Radiological Health
- Office URL: /offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7
- Issue Date: 2022-08-17
- Last Changed: 2022-08-16
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2017-D-6765">FDA-2017-D-6765</a>

## Related Documents

- [Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/clarification-of-radiation-control-regulations-for-manufacturers-of-diagnostic-x-ray-equipment-guidance-for-industry-and-food-and-drug-administration-staff/9af128f7-1996-449d-9119-722799a49720)
- [Radiation Biodosimetry Medical Countermeasure Devices:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/radiation-biodosimetry-medical-countermeasure-devices-guidance-for-industry-and-food-and-drug-administration-staff/9c7e3c75-b0cc-449b-88ea-9506971780ec)
- [Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/highly-multiplexed-microbiologicalmedical-countermeasure-in-vitro-nucleic-acid-based-diagnostic-devices-guidance-for-industry-and-food-and-drug-administration-staff/1aa959b8-c546-4122-96a9-3e538a3c1b7f)
