FDA does not require submission of a paper copy for electronic submissions submitted using the FDA ESG.
FDA forms (e.g., 1571, 356h) and documents require a signature. Accepted signature methods by FDA are:
- Scanned signatures
- Digital signatures
- Flattened digital signatures. A flattened digital signature must include (see example):
- the printed name of the signer
- the date and time when the signature was executed
- the reason for signature
Please use the Adobe Acrobat Self-Sign plug-in to insert your signature on fillable FDA forms.
The FDA cannot hold digital signatures to a higher standard than paper signatures. The FDA will not check the signature on an electronic or paper-based submission unless there is a directed inspection involving that submission. Please maintain the security certificates associated with your digital signatures in case of a directed inspection.
The FDAAs General Counsel (GC) has said that the FDA must be able to determine the origin of a submission in order to implement fully electronic submissions. The PKI (x.509 version 3 class I) certificate employed by the ESG allows the FDA to determine the origin of the submission through the use of a public/private key exchange.
Please use the 1571 (http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083533.pdf) and 356h (http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/ucm082348.pdf) fillable PDF forms with your electronic submissions to CDER and CBER via the ESG.
- If you do not include these forms with your electronic submissions, CBER and CDER will not be able to leverage their automated loading processes, reducing the process to a manual one. This results in a large increase in the time required by the Centers to make submissions available to our review community.
- 356h and 1571 Form Field Sizes
- For documents sent through the ESG for regulatory review, the most important form fields from the FDAAs perspective are the application number and the submission type.
- The current form fields have the maximum number of characters allowed. If a form field is not large enough, please abbreviate the text in the field. Increasing the size of a form field or otherwise altering a form would require OMB approval.
- FDA contractors or administrative reviewers read a submissionns cover letter and selected text to determine the nature and content of the submission. FDA-generated data and information is utilized in FDA submission tracking databases.
Example of a flattened digital signature:
Frequently Asked Questions about Digital Signatures
Q. A question mark (?) appears if I don't use PDF Self-Sign to create a signature. Will the FDA accept such a submission?
A. Yes. The FDA will not validate a signature during the submission process unless there is a directed inspection of the submission.
Q. What if I can't fit my full text into a form field?
A. The most important form fields are the application number field and the submission type field.
Q. Because I used a non-public key digital signature, I received an error message during the eCTD validation steps regarding a "secured" PDF file being present within the eCTD. Will my submission still be accepted?
A. The FDA understands that this can occur and will not reject submissions based on this.