Implementing the FDA’s fillable forms has been challenging for many small companies. While the advantages of using the forms are clear, many companies find the process daunting. Fortunately, there are some easy paths to implementation that do not require large-scale process or system changes.
First, it’s important to remember why the forms are useful. For companies using the Electronic Submissions Gateway (ESG), the forms provide a way for submissions to get to reviewers without requiring human intervention. The gateway is programmed to look for files named 1571.pdf or 356h.pdf. If those files were created with the fillable forms, the gateway reads the application and sequence numbers from the form and automatically routes the submission. This is the fastest way to get submissions from your company to reviewers.
If you don’t use the fillable forms, your submissions end up in the Electronic Document Room, where someone has to open up the pdf file to figure out the submission and sequence numbers. This process can delay delivery of your submission to reviewers by up to a week.
So how best to implement the forms? There are 2 basic approaches: use Acrobat self-sign certificates, or send unsigned forms with a scanned version of the printed form. I'll describe how each approach works.
Fillable Form Plus Scanned Form With Signature
If you are uncomfortable digitally signing the form, you can send an unsigned fillable form along with a scanned version of the signed, printed form. Both forms go in the same place in m1. The fillable form needs to be named 1571.pdf or 356h.pdf. The scanned form can be named something like scanned-form.pdf, but the name must not contain the form number.
Fillable Form With Electronic Signature
To streamline this process, consider using Acrobat self-sign certificates. These certificates enable anyone with Acrobat to add their digital signature to a document. Before you begin you have to send a non-repudiation letter to the agency stating that your company recognizes digital signatures as the equivalent of paper signatures. This is a simple letter, but you may want to discuss its contents and implications with your legal and QA departments before sending.
To implement the process, you go to each potential signatory’s computer and help them create a certificate from within Acrobat (it varies slightly depending on which version of Acrobat you’re using). The signers should save a copy of the signature file on their laptop (in case they need to sign something while traveling) and a second copy in a secure location on your network. They need to use a password that they will remember--they have to use the password each time they sign a document.
Once you’ve set this up it’s very easy to actually sign a document. A signer clicks on the signature block on the form, selects their certificate file, enters their password, and selects a reason for signing from the popup list. The whole thing takes only slightly longer than a paper signature.
For more information on digital signatures and fillable forms, check out this FDA guidance: Electronic Signatures Guidance