FDA Check
Overview
FDA Check is an Adobe Acrobat plug-in that validates PDF documents against the FDA’s Portable Document Format (PDF) Specifications for electronic regulatory submissions (eCTD). It checks fonts, page layout, security settings, image compression, bookmarks, and more, then produces an HTML report listing any issues found.
Version 1.5.2
Getting Started
After installation, FDA Check adds two items under the Plugins/Mapsoft menu in Adobe Acrobat:
- FDA Check — Opens the validation dialog for the active PDF document.
- FDA Spec — Opens the official FDA PDF Specification in your default web browser.
FDA Check requires the full version of Adobe Acrobat (not Acrobat Reader).
Running a Validation
- Open a PDF document in Adobe Acrobat.
- Go to Plug-ins/Mapsoft > Mapsoft > FDA Check.
- In the dialog, select or deselect individual checks as needed, or use Select all to toggle all checks at once.
- Click Run Check to validate the document.
When validation completes, an HTML report opens in your default web browser. The report lists each issue found as a bullet point, including the page number where applicable.
Your check selections are saved automatically and restored the next time you open the dialog.
Validation Checks
The following table describes each check and what it validates, based on the FDA’s Portable Document Format (PDF) Specifications.
| Check | What It Validates |
|---|---|
| PDF version | The document must be PDF version 1.4, 1.5, 1.6, or 1.7. PDF/A-1 and PDF/A-2 documents are also accepted as they are based on these versions. |
| Security settings | The document must not be encrypted or password-protected. No security handler of any kind is permitted. |
| Font embedding | All fonts must be fully embedded with their complete character sets. Subset embedding (where only used characters are included) is not acceptable. Unembedded fonts are also flagged. |
| Page orientation and size | All pages must be US Letter size (8.5 × 11 inches). Both portrait and landscape orientations are accepted. Each non-conforming page is reported by page number. |
| Initial view settings | If the document has bookmarks, the initial view must be set to Bookmarks Panel and Page. If there are no bookmarks, the initial view must be Page Only. The page layout should be set to default. Full-screen mode is not permitted. |
| Text searchable | The document must contain searchable (extractable) text. Image-only documents (e.g., scanned pages without OCR) are flagged. |
| JavaScript and dynamic content | The document must not contain JavaScript (in name trees, open actions, or additional actions), file attachments, or multimedia/3D annotations (Movie, Sound, Screen, RichMedia, or 3D). |
| Hypertext links and bookmarks | The document should contain valid bookmarks. Hypertext links are checked for valid actions. Links that use absolute local file paths (drive letters or UNC paths) are flagged — the FDA requires relative paths so that links work on their servers. |
| Annotations | Annotations other than hypertext links (Link) and form fields (Widget) are not permitted. Prohibited annotations are reported by type and page number. |
| Image compression | Only lossless compression methods are allowed: Flate/ZIP (FlateDecode) and CCITT Group 4 Fax (CCITTFaxDecode). Lossy methods such as JPEG and JPEG2000 are flagged. |
| Fast web view | The document must be optimized for fast web view (linearized). |
| Font sizes and names | Font sizes must be between 9 and 12 points. Only the following standard fonts are allowed: Times New Roman, Arial, Courier New, Symbol, and ZapfDingbats. Non-standard fonts and out-of-range sizes are reported individually. |
| Table of contents and bookmarks | Documents with 5 or more pages must contain bookmarks. Bookmarks must not exceed 4 levels of nesting, must have valid actions, and must use the Inherit Zoom magnification setting. |
| Image color model | Images should use a standard color space. CMYK is preferred for print consistency, but RGB and grayscale are also accepted. ICC-based and calibrated color spaces are permitted. Unsupported color spaces (such as Indexed, Separation, or DeviceN) are flagged. |
Validation Report
The validation report is saved as an HTML file at:
%TEMP%\FDACheck_log.htmlThis is typically located at C:\Users\<username>\AppData\Local\Temp\FDACheck_log.html. The report is overwritten each time you run a validation. If you need to keep a report, save or rename the file before running another check.
Each issue is listed as a separate item. Where applicable, the page number and specific details (such as the font name or annotation type) are included to help you locate and resolve the problem.
Settings
Your check selections are stored in the Windows Registry at:
HKEY_CURRENT_USER\Software\PDFValidationEach check is stored as a DWORD value (1 = enabled, 0 = disabled). If no settings have been saved, all checks default to enabled.
System Requirements
- Adobe Acrobat (full version, not Reader)
- Windows 10 or later (64-bit)
Support
For questions, bug reports, or feature requests, please contact Mapsoft Computer Services.