# Providing Regulatory Submissions in Electronic Format Orphan-Drug and Humanitarian Use Device Designation Requests and Related Submissions: Draft Draft Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/providing-regulatory-submissions-in-electronic-format-orphan-drug-and-humanitarian-use-device-designation-requests-and-related-submissions-draft-draft-guidance-for-industry/cac61e0f-25c5-4efc-9f40-f3703a350a46

> FDA guidance document: Providing Regulatory Submissions in Electronic Format Orphan-Drug and Humanitarian Use Device Designation Requests and Related Submissions: Draft Draft Guidance for Industry. Issue date: February 01, 2006. Get complete insights and analysis.

---

## Details

- Title: Providing Regulatory Submissions in Electronic Format Orphan-Drug and Humanitarian Use Device Designation Requests and Related Submissions: Draft Draft Guidance for Industry
- Communication Type: Guidance Document
- Product Type: devices
- Office Name: Office of the Commissioner
- Office URL: /offices/office-of-the-commissioner/79483979-9582-427f-ac3d-46c715811424
- Issue Date: 2006-02-01
- Last Changed: 2021-05-13
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2006-D-0159">FDA-2006-D-0159</a>

## Related Documents

- [FDA Records Access Authority for Cosmetic Products: Draft Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/fda-records-access-authority-for-cosmetic-products-draft-guidance-for-industry/8d135c40-7a5b-4b46-9a37-a2153689ab77)
- [Hernia Mesh – Package Labeling Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/hernia-mesh-package-labeling-recommendations-draft-guidance-for-industry-and-food-and-drug-administration-staff/f3f2df12-07bc-40dd-9050-853b9e9e58a8)
- [List of Highest Priority Devices for Human Factors Review: Draft Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/list-of-highest-priority-devices-for-human-factors-review-draft-guidance-for-industry-and-food-and-drug-administration-staff/0dc7b489-3bcc-4d2a-b052-209e46552610)