Electronic Copy (eCopy) Program for Medical Device Submissions: Technical Standards and Requirements
This guidance explains the eCopy Program for medical device submissions, implementing section 745A(b) of the FD&C Act. It provides standards for submitting electronic copies (eCopies) of medical device submissions to FDA, aiming to improve review efficiency by making electronic versions immediately available.
Recommended Actions
- Determine if your submission type requires an eCopy
- Plan submission structure (volume-based or non-volume-based)
- Prepare signed cover letter following requirements
- Convert documents to compliant PDF format (Adobe v11 or below, <50MB)
- Follow required naming conventions for files and folders
- Organize non-PDF files in appropriate folders (STATISTICAL DATA or MISC FILES)
- Validate eCopy using FDA’s eCopy Validation Module before submission
- Submit eCopy on CD, DVD, or flash drive with paper copy of signed cover letter
- Consider using FDA’s free eSubmitter-eCopies tool to ensure compliance
- Plan for potential eCopy hold response within 180 days if issues are found
Key Considerations
Software
- Only Adobe Acrobat PDF version 11 or below is accepted
- No embedded attachments or attributes in PDFs
- No PDFs requiring passwords to open
- PDF file size limited to 50MB or below
- Statistical data and other non-PDF files must be submitted in zip format under specific folders
Cybersecurity
- No security settings requiring passwords to open PDFs
- No embedded attachments that could compromise security
Labelling
- Labeling documents should be provided in both PDF and Microsoft Word formats (Word version in MISC FILES folder)
Other considerations
- eCopy must include a signed cover letter (wet or digital signature)
- Specific naming conventions required for volumes and files
- Maximum recommended total submission size of 1GB
- Specific folder structure requirements for volume-based and non-volume-based submissions
- Statistical data must be submitted in “STATISTICAL DATA” folder
- Miscellaneous files must be submitted in “MISC FILES” folder
Original guidance
- Electronic Copy (eCopy) Program for Medical Device Submissions: Technical Standards and Requirements
- HTML / PDF
- Issue date: 2020-04-27
- Last changed date: 2023-08-10
- Status: FINAL
- Official FDA topics: Medical Devices, Premarket, Biologics, Investigational Device Exemption (IDE), Administrative / Procedural, User Fees
- ReguVirta summary file ID: 32d26af111ca2f374cc11098e887dc81
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