# Investigational Device Exemptions (IDEs) for Devices Indicated for Nocturnal Home Hemodialysis:  Guidance for Industry and FDA Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/investigational-device-exemptions-ides-for-devices-indicated-for-nocturnal-home-hemodialysis-guidance-for-industry-and-fda-staff/7c63ae38-9eff-4af8-8dcd-c0612c8198e2

> FDA guidance document: Investigational Device Exemptions (IDEs) for Devices Indicated for Nocturnal Home Hemodialysis:  Guidance for Industry and FDA Staff. Issue date: April 15, 2008. Get complete insights and analysis.

---

## Details

- Title: Investigational Device Exemptions (IDEs) for Devices Indicated for Nocturnal Home Hemodialysis:  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: 2008-04-15
- Last Changed: 2020-03-20
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2020-D-0957">FDA-2020-D-0957</a>

## Related Documents

- [Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/policy-clarification-and-premarket-notification-510k-submissions-for-ultrasonic-diathermy-devices-guidance-for-industry-and-food-and-drug-administration-staff/ab06388f-a3b0-4c35-a1b7-ab5befb36526)
- [The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/the-content-of-investigational-device-exemption-ide-and-premarket-approval-pma-applications-for-artificial-pancreas-device-systems-guidance-for-industry-and-food-and-drug-administration-staff/692e0ca7-0e58-43e0-92f6-1f2f471e307d)
- [Infusion Pumps Total Product Life Cycle:  Guidance for Industry and FDA Staff](https://www.globalkeysolutions.net/guidances/guidance-document/infusion-pumps-total-product-life-cycle-guidance-for-industry-and-fda-staff/8463ac86-803f-45c8-a325-558ae011327d)