# Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program:  - Final Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/requests-for-feedback-and-meetings-for-medical-device-submissions-the-q-submission-program-final-guidance-for-industry-and-food-and-drug-administration-staff/56b237df-6d34-4ac7-b71b-a29b57e8cc71

> FDA guidance document: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program:  - Final Guidance for Industry and Food and Drug Administration Staff. Issue date: May 29, 2025. Get complete insights and analysis.

---

## Details

- Title: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program:  - Final 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: 2025-05-29
- Last Changed: 2025-05-28
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2018-D-1774">FDA-2018-D-1774</a>

## Related Documents

- [Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices:   Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/use-of-real-world-evidence-to-support-regulatory-decision-making-for-medical-devices-guidance-for-industry-and-food-and-drug-administration-staff/d18b3a42-ad8b-4987-8955-ea08f4372049)
- [Electronic Submission Template for Medical Device De Novo Requests:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/electronic-submission-template-for-medical-device-de-novo-requests-guidance-for-industry-and-food-and-drug-administration-staff/8bd49234-647d-4582-b2b5-adc2a5d75f1c)
- [Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/cybersecurity-in-medical-devices-quality-system-considerations-and-content-of-premarket-submissions-guidance-for-industry-and-food-and-drug-administration-staff/f60f693d-5633-45fe-bd51-0326ab2a951d)
