Regulatory Information

Providing Regulatory Submissions in Electronic Format Orphan-Drug and Humanitarian Use Device Designation Requests and Related Submissions

Draft Guidance for Industry

Guidance document (PDF - 123KB)

This is one in a series of guidance documents intended to assist sponsors making regulatory submissions to the Office of Orphan Products Development (OPD) in electronic format using the FDA Electronic Submissions Gateway (ESG) pathway or directly to OPD on physical media (e.g., CD-ROMs). This guidance discusses issues related to the electronic submission of requests for orphan-drug designation, humanitarian use device designation (HUD), and related submissions.

The goals of this guidance are to enhance the receipt, processing, review, and archiving of electronic submissions to OPD.

In October 2003, the Food and Drug Administration (FDA) issued the draft guidance for industry Providing Regulatory Submissions in Electronic Format — General Considerations. The General Considerations Guidance discusses issues common to all types of electronic regulatory submissions, such as acceptable file formats, physical media and submission procedures. As set forth under Part 11, Title 21, Code of Federal Regulations, for records submitted to the FDA, sponsors may elect to use electronic records in lieu of paper records, in whole or part, provided the requirements of Part 11 are met and the documents or parts of documents to be submitted have been identified by the FDA in public docket No. 92S-0251 as being the type of submission it is prepared to accept in electronic format.

Page Last Updated: 07/12/2018
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English