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:
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.
Consult with an FDA Center representative to determine which signature method is required for each type of submission.
Example of a flattened digital signature:
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.