eCopy Program for Medical Device Submissions - Guidance for Industry and FDA Staff

Sep 13, 2026

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Nonbinding recommendations define how medical device submissions to the Food and Drug Administration should use electronic copies under the eCopy Program. The guidance explains what an eCopy is, when eCopies are required, and which submission types may be eligible or exempt. It outlines copy requirements, processing steps, and technical standards, including recommended methods for creating PDF files and handling hyperlinks and bookmarks.

LanguageEnglish

CategoryLetters

FormatPDF

Pages34

Reading Time12 min

AccessFree to download

Introduction

What is an eCopy?

eCopy requirements and eligible submission types

Copies needed for submissions

Processing steps for an eCopy

Technical standards and recommended creation methods

Bookmarks and hyperlinks within PDFs

Creating a PDF file from the source document (preferred)

Creating a PDF file from a scanned document

Submitting an eCopy and FDA processing

Managing holds, replacement eCopies, and timeframes

Contains Nonbinding Recommendations eCopy Program for Medical Device Submissions Guidance for Industry and Food and Drug Administration Staff Document issued on December 3, 2015. This document supersedes the guidance of the same title dated October 10, 2013. For questions regarding this document, contact CDRH’s eCopy Program Coordinators at 240- 402-3717 or [cdrh-eCopyinfo@fda.hhs.gov](cdrh-eCopyinfo@fda.hhs.gov) or CBER’s Office of Communication, Outreach and Development, at 1-800-835-4709 or 240-402-8010. U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Center for Biologics Evaluation and Research Contains Nonbinding Recommendations Preface Public Comment You may submit electronic comments and suggestions at any time for Agency consideration to [http://www.regulations.gov](http://www.regulations.gov. Submit written comments)[. Submit written comments](http://www.regulations.gov. Submit written comments) to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061,(HFA-305), Rockville, MD, 20852. When submitting comments, please refer to the exact title of this guidance document. Comments may not be acted upon by the Agency until the document is next revised or updated. Additional Copies Additional copies are available from the Internet. You may also send an e-mail request to CDRHGuidance@fda.hhs.gov to receive an electronic copy of the guidance. Please use the document number (1797) to identify the guidance you are requesting. Additional copies of this guidance document are also available from the Center for Biologics Evaluation and Research (CBER), Office of Communication, Outreach, and Development (OCOD), 10903 New Hampshire Ave., Bldg. 71, Room 3128, Silver Spring, MD 20993-0002, or by calling 1-800-835-4709 or 240-402-8010, [by emailing](by emailing ocod@fda.hhs.gov)[ ](by emailing ocod@fda.hhs.gov)[ocod@fda.hhs.gov](by emailing ocod@fda.hhs.gov), or from the Internet at [http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.h](http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.h)tm. Table of Contents 1. Introduction ................................................................................................................................................. 1 2. What is an eCopy?....................................................................................................................................... 3 3. Are differences between the contents of an eCopy and paper submission acceptable? .............................. 3 4. For what submission types is an eCopy required?....................................................................................... 4 5. Are there other submission types not subject to the eCopy legislation for which eCopies may be submitted?.................................................................................................................................................... 5 6. How many copies of a submission are needed? .......................................................................................... 6 7. What are the processing steps for an eCopy? .............................................................................................. 7 a. What are the technical standards for an eCopy? ............................................................................... 7 b. What are the recommended methods for creating an eCopy? ........................................................... 7 A. Bookmarks and Hyperlinks within PDFs ...................................................................................... 7 B. Creating a PDF File from the Source Document (Preferred)....................................................... 8 C. Creating a PDF File from a Scanned Document ..................................................

FAQs

What is an eCopy for medical device submissions?

An eCopy is the electronic version used for certain medical device submissions to FDA under the eCopy Program. The guidance explains its definition and purpose in the submission workflow.

When is an eCopy required, and for which submission types?

The guidance specifies for what submission types an eCopy is required and which other submission types may allow eCopies under relevant rules. It also addresses differences between eCopy and paper contents.

What are the key processing steps and technical standards for an eCopy?

The document provides processing steps and technical standards, including recommended methods for creating an eCopy. It covers PDF creation approaches, including handling bookmarks and hyperlinks, and how to verify technical compliance before sending to FDA.

Sep 13, 2026

Upload by Gloria