# Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A:  Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/center-for-devices-and-radiological-health-cdrh-appeals-processes-questions-and-answers-about-517a-guidance-for-industry-and-food-and-drug-administration-staff/0760caf5-5027-4b32-a213-747c43f5d018

> FDA guidance document: Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A:  Guidance for Industry and Food and Drug Administration Staff. Issue date: March 27, 2020. Get complete insights and analysis.

---

## Details

- Title: Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A:  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: 2020-03-27
- Last Changed: 2025-11-19
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2013-D-0501">FDA-2013-D-0501</a>

## Related Documents

- [Center for Devices and Radiological Health (CDRH) Appeals Processes:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/center-for-devices-and-radiological-health-cdrh-appeals-processes-guidance-for-industry-and-food-and-drug-administration-staff/70529c89-1313-4132-a42a-4f0b2e1bb4f5)
- [Providing Regulatory Submissions for Medical Devices in Electronic Format - Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/providing-regulatory-submissions-for-medical-devices-in-electronic-format-submissions-under-section-745ab-of-the-federal-food-drug-and-cosmetic-act-guidance-for-industry-and-food-and-drug-administration-staff/fc3853a4-7287-48ef-a363-32e3dfef666c)
- [Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/postmarket-surveillance-under-section-522-of-the-federal-food-drug-and-cosmetic-act-guidance-for-industry-and-food-and-drug-administration-staff/f631d61d-d1a4-451d-84c0-b22c554e8218)
