# Antimicrobial Susceptibility Test (AST) System Devices – Updating Breakpoints in Device Labeling:  Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/antimicrobial-susceptibility-test-ast-system-devices-updating-breakpoints-in-device-labeling-guidance-for-industry-and-food-and-drug-administration-staff/75f8c8db-da73-47f6-af44-69ed63ea0312

> FDA guidance document: Antimicrobial Susceptibility Test (AST) System Devices – Updating Breakpoints in Device Labeling:  Guidance for Industry and Food and Drug Administration Staff. Issue date: September 29, 2023. Get complete insights and analysis.

---

## Details

- Title: Antimicrobial Susceptibility Test (AST) System Devices – Updating Breakpoints in Device Labeling:  Guidance for Industry and Food and Drug Administration 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: 2023-09-29
- Last Changed: 2023-09-28
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2023-D-4045 ">FDA-2023-D-4045 </a>

## Related Documents

- [General Considerations for Animal Studies Intended to Evaluate Medical Devices:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/general-considerations-for-animal-studies-intended-to-evaluate-medical-devices-guidance-for-industry-and-food-and-drug-administration-staff/20618a6e-ba4f-4f65-bbc8-b7b05e3afc90)
- [Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/submission-of-premarket-notifications-for-magnetic-resonance-diagnostic-devices-guidance-for-industry-and-food-and-drug-administration-staff/374fccc3-2ae3-4a94-b9f0-7042a3429a1d)
- [Pediatric Information for X-ray Imaging Device Premarket Notifications:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/pediatric-information-for-x-ray-imaging-device-premarket-notifications-guidance-for-industry-and-food-and-drug-administration-staff/7a347f68-87ec-48b0-b385-4a82d1ebd6a3)