FDA Checker
User Guide — Mapsoft FDA Checker Plugin for Adobe Acrobat
Overview
FDA Checker is an Adobe Acrobat plug-in that validates PDF documents against the FDA’s Portable Document Format (PDF) Specifications for electronic Common Technical Document (eCTD) submissions. The pharmaceutical and medical device industries are required to submit regulatory documents to the FDA in PDF format that meets strict technical requirements regarding fonts, page size, security, annotations, and other document properties.
FDA Checker performs 14 individual validation checks covering all key requirements from the FDA specification. Each check can be independently enabled or disabled, and results are presented in a detailed HTML report that identifies every issue found, including the specific page and element that triggered the finding. This allows document authors to quickly identify and resolve compliance issues before submission.
The plug-in installs as FDACheck.api in the Acrobat plug-ins directory and adds two menu items under Extensions › Mapsoft: FDA Check to run validation, and FDA Spec to open the FDA’s PDF specification document in your web browser for reference.
Getting Started
After installation, FDA Checker adds menu items to Adobe Acrobat. To validate a document:
- Open the PDF document you wish to validate in Adobe Acrobat.
- Go to Extensions › Mapsoft › FDA Check.
- The FDA Checker dialog will appear with 14 validation checkboxes, a Select All toggle, and Run Check / Cancel buttons.
- Enable or disable individual checks as needed, then click Run Check.
The validation runs on the currently open document. After processing completes, a summary message shows the total number of issues found and offers to open the detailed HTML report. Each checkbox in the dialog also has a tooltip that describes what the check validates, visible by hovering your mouse over it.
HKCU\Software\PDFValidation) and restored the next time you open the dialog. This means your preferred check selection persists between sessions.
Validation Checks
FDA Checker performs the following 14 validation checks, each corresponding to a requirement in the FDA’s PDF specification:
| # | Check | What It Validates |
|---|---|---|
| 1 | PDF Version | Verifies the PDF version is between 1.4 and 1.7. Older or newer versions may not be accepted by FDA systems. |
| 2 | Security | Checks that the document has no encryption or password protection. FDA submissions must be freely accessible without passwords. |
| 3 | Font Embedding | Verifies all fonts are fully embedded (not subset-embedded). This ensures the document renders identically on any system. |
| 4 | Page Orientation & Size | Checks all pages are US Letter size (8.5 × 11 inches) in either portrait or landscape orientation. |
| 5 | Initial View Settings | Validates PageMode and PageLayout settings and ensures the document does not open in fullscreen mode. |
| 6 | Text Searchable | Verifies the document contains extractable, searchable text — not just scanned images of text. |
| 7 | JavaScript & Dynamic Content | Checks for the presence of JavaScript, file attachments, multimedia content, or 3D objects, all of which are prohibited in FDA submissions. |
| 8 | Hypertext Links & Bookmarks | Validates that bookmarks have valid destinations, hypertext links use valid actions, and link paths are relative rather than absolute. |
| 9 | Annotations | Checks that no annotations exist except Link and Widget types. Sticky notes, stamps, highlights, and other markup annotations are not permitted. |
| 10 | Image Compression | Verifies that all images use only FlateDecode or CCITTFaxDecode compression. JPEG, JPEG2000, and other lossy formats may cause issues. |
| 11 | Fast Web View | Checks that the document is linearized (optimized for fast web viewing), which allows progressive download. |
| 12 | Font Sizes & Names | Validates that font sizes are between 9 and 12 points, and only approved font families are used: Times New Roman, Arial, Courier New, Symbol, and ZapfDingbats. |
| 13 | TOC & Bookmarks | Requires bookmarks for documents with 5 or more pages, limits bookmark nesting to a maximum of 4 levels, and verifies bookmarks use the Inherit Zoom setting. |
| 14 | Image Color Model | Verifies images use CMYK, RGB, grayscale, or ICC-based color spaces. Spot colors and other non-standard color models are flagged. |
Running a Check
To run validation, enable the checks you want to perform using the checkboxes in the dialog, then click Run Check (the OK button). The plug-in processes the currently open document, examining every page and every relevant element (fonts, annotations, images, bookmarks, etc.) against the selected requirements.
During validation, each check function inspects the document structure at the Cos (low-level PDF object) level for maximum accuracy. Font embedding is verified by examining font descriptor dictionaries, image compression is checked by inspecting stream filter arrays, and page sizes are computed from media box coordinates. This ensures that findings are based on the actual PDF structure rather than high-level approximations.
The HTML report logger automatically deduplicates findings — if the same issue appears on multiple pages, it is reported once rather than flooding the report with repeated messages. After all selected checks complete, a summary dialog shows the total number of issues found.
Viewing Results
After validation completes, FDA Checker generates a detailed HTML report and displays a summary message indicating how many issues were found. You can choose to open the HTML report immediately in your default web browser.
The HTML report is organized by check category and lists each finding with details about the specific page, element, or property that triggered the issue. For font-related checks, the report includes the font name and embedding status. For page size issues, it shows the actual dimensions compared to the expected US Letter size. For annotation issues, it identifies the annotation type and page number.
The report can be saved, printed, or shared with colleagues for collaborative remediation. Since it is a standard HTML file, it opens in any web browser without additional software.
Select All / Deselect All
The Select All checkbox at the top of the dialog provides a convenient way to enable or disable all 14 validation checks at once. When checked, all validation checkboxes are enabled; when unchecked, all are disabled.
The Select All checkbox also reflects the current state of the individual checkboxes — it appears checked only when all 14 checks are enabled. If you manually disable even one check, the Select All checkbox will automatically uncheck to indicate that not all checks are active.
This is useful when you want to run a comprehensive validation (select all) or when you want to focus on a specific area (deselect all, then enable only the checks you need).
System Requirements
- Adobe Acrobat: Acrobat Pro or Standard DC (2017 or later). Not compatible with Acrobat Reader.
- Operating System: Windows 10 or Windows 11 (32-bit and 64-bit Acrobat installations both supported).
- Web Browser: Any modern web browser for viewing the HTML validation report.
- FDA Specification: The FDA Spec menu item opens the FDA’s specification document in your browser for reference. An internet connection is required for this feature.
Support
If you encounter a problem or have a question not covered here, please get in touch:
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