Does the FDA Accept PDF/A?

Email this to someonePrint this pageShare on LinkedIn0Tweet about this on TwitterShare on Google+0

Recently a client asked me if the FDA would accept a PDF/A document. The short answer is yes, but I would not build your system based on the PDF/A standard. I will explain why below.

PDF/A is an ISO-standardized version of the Portable Document Format (PDF) specialized for the digital preservation of electronic documents. PDF/A differs from PDF by omitting features ill-suited to long-term archiving, such as font linking (as opposed to font embedding). PDF/A-1 is based on the PDF Reference Version 1.4 from Adobe Systems Inc. (implemented in Adobe Acrobat 5 and latest versions) and is defined by ISO 19005-1:2005, an ISO Standard that was published on October 1, 2005:

Below is a snippet from the FDA’s PDF Specifications
(http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM163565.pdf)

PDF versions 1.4 through 1.7 are acceptable. Submitted PDF files should be readable by Adobe Acrobat 8.0, should not require additional software or plug-ins to be read and navigated, and should be text searchable. If plug-ins are used during the creation of a PDF document, prior to submitting the document, ensure that a plug-in is not needed for review or archive.

The specifications for PDFs are backward inclusive. The PDF 1.7 specification includes all of the functionality previously documented in the Adobe PDF Specifications for versions 1.0 through 1.6. Therefore any agency that accepts PDF 1.7 (or PDF 1.4) will accept PDF 1.0.

This is also true for PDF/A. Since all PDF/A files are PDF 1.4 files.

The problem with PDF/A is that many believe that PDF/A does not support links external to the document are valid. The following article refutes that claim (http://www.ebriefpro.com/pdfs/pdfa.pdf).

Regardless, if PDF/A actually allows links external to the document, some rendering tools will strip out external links when complying to PDF/A.

In conclusion, yes the FDA will accept PDF/A since there is no way to distinguish a PDF/A from PDF 1.4; however, your rendering tool might remove your important cross-document links. Thus, I would not recommend building your systems around the PDF/A standard.

Author: Jason Rock

Jason Rock is a pioneer in the field of electronic submissions. Mr. Rock has an extensive background working with global life sciences companies and regulatory agencies to promote eCTD adoption through the development of advanced applications. The commercial software Mr. Rock originally developed, and continues to improve, in his role as Chief Technical Officer for GlobalSubmit, is used exclusively by the U.S. Food & Drug Administration to review and validate all eCTD submissions the FDA receives.

Share This Post On

Submit a Comment