Can I use electronic signatures on FDA Forms?

Yes. Electronic signatures are generally legally valid under ESIGN (15 U.S.C. §7001) and state UETA laws for most FDA Forms; however, check specific program guidance and exceptions, and ensure intent, consent, attribution, and reliable record retention are documented.

Do FDA submissions require notarization?

Not typically. Most FDA electronic submissions do not require notarization; signatures and attestations should meet ESIGN/UETA tests. Certain state-level legal documents or court filings may require notarization or witnesses—confirm with the receiving office.

What are the most common submission errors?

Incomplete fields, mismatched legal names, missing lot or NDC identifiers, unsupported file formats, and unsigned signature blocks are frequent causes of rejection or requests for clarification. Use validated templates to reduce avoidable corrections and delays.

How long must I retain FDA submission records?

Retention depends on document type and regulator. Follow federal minimums such as IRS three years (IRC §6501(a)) and HIPAA six years (45 CFR §164.530(j)), and keep signed submission archives per ESIGN reproduction requirements.

What happens if a form is incorrect after filing?

Errors can trigger processing delays, deficiency letters, inspections, or enforcement. Incomplete or inaccurate information may require corrective submissions or supplements. Consult regulatory affairs or legal counsel for amendment or voluntary disclosure guidance.

Who is authorized to sign FDA Forms?

An authorized representative of the registrant, sponsor, or manufacturer must sign where required. Authority commonly resides with senior regulatory, quality, or legal officers and should be documented to demonstrate signer attribution.

FDA Forms

This template is fully customizable. Edit the text, fill out the fields, and send it for signature. Give it a try!

NOTIFICATION OF CANCELLATION OR DISSOLUTION OF BUSINESS

STATE OF ILLINOIS

COUNTY OF COOK

)

For office use only

Certificate #

Submit completed form and a check for $1.50 payable to:

Cook County Clerk David Orr

Bureau of Vital Statistics

Attn: Assumed Name Registration Unit

P.O. Box 642570

Chicago, IL 60602-2570

Let it be known that the Business

has cancelled or dissolved as of

Location of Business:

The undersigned (print names of all owners, using reverse for additional names)

was/were the proprietor(s) of the Business.

Dated this day of

Signature

I,

a Notary Public in Cook County, IL, do hereby certify that [record owner(s) name(s) below]

is/are personally known to me to be the same person(s) whose name(s) subscribed to the foregoing instrument appeared before me this day in person and acknowledged that he/she read and signed the instrument and that the statements therein contained, and each thereof, are true.

Notary Public

(signature)

My commission expires on the day of

What FDA Forms Are and when they apply

FDA Forms are the standardized documents used to communicate regulatory information to the U.S. Food and Drug Administration across product categories including drugs, medical devices, biologics, food, and tobacco. They cover submissions such as investigational applications, premarket notifications, adverse event reports, establishment registrations, and labeling updates. Properly completed FDA Forms establish a clear administrative record, support regulatory review, and help meet statutory filing requirements. Organizations must follow the form instructions, applicable CFR provisions, and any FDA guidance to avoid processing delays or noncompliance findings during inspections or submissions.

Why accurate FDA Forms matter

Accurate FDA Forms reduce review delays, demonstrate regulatory compliance, and provide an auditable record for inspections. Completing forms correctly minimizes the risk of refusal, enforcement action, or costly resubmissions and supports traceability across the product lifecycle and quality systems.

Who prepares and signs FDA Forms

Regulatory, quality, and clinical teams typically prepare and submit FDA Forms within regulated organizations.

Manufacturers and distributors responsible for registrations, adverse event reports, and establishment listings.
Clinical investigators and sponsors filing investigational submissions and amendments for trials.
Regulatory affairs, quality assurance, and in-house counsel overseeing compliance and inspection readiness.

Step-by-step: completing an FDA Form

Follow a sequential approach to complete FDA Forms accurately, verify supporting documents, and confirm authorized signatures before submission.

01

Prepare: Gather product data, lot numbers, and required attachments before starting the form.
02

Complete: Enter required fields precisely using MM/DD/YYYY for dates and full legal names.
03

Review: Cross-check entries against quality and regulatory records; correct discrepancies.
04

Submit: Send via FDA electronic gateway or designated portal and retain receipt.

Common questions about signing, submitting, and retaining FDA Forms

Answers to frequent questions about eSignatures, submission methods, retention, and common filing pitfalls for FDA Forms.

Need help? Contact support

Can I use electronic signatures on FDA Forms?
Yes. Electronic signatures are generally legally valid under ESIGN (15 U.S.C. §7001) and state UETA laws for most FDA Forms; however, check specific program guidance and exceptions, and ensure intent, consent, attribution, and reliable record retention are documented.
Do FDA submissions require notarization?
Not typically. Most FDA electronic submissions do not require notarization; signatures and attestations should meet ESIGN/UETA tests. Certain state-level legal documents or court filings may require notarization or witnesses—confirm with the receiving office.
What are the most common submission errors?
Incomplete fields, mismatched legal names, missing lot or NDC identifiers, unsupported file formats, and unsigned signature blocks are frequent causes of rejection or requests for clarification. Use validated templates to reduce avoidable corrections and delays.
How long must I retain FDA submission records?
Retention depends on document type and regulator. Follow federal minimums such as IRS three years (IRC §6501(a)) and HIPAA six years (45 CFR §164.530(j)), and keep signed submission archives per ESIGN reproduction requirements.
What happens if a form is incorrect after filing?
Errors can trigger processing delays, deficiency letters, inspections, or enforcement. Incomplete or inaccurate information may require corrective submissions or supplements. Consult regulatory affairs or legal counsel for amendment or voluntary disclosure guidance.
Who is authorized to sign FDA Forms?
An authorized representative of the registrant, sponsor, or manufacturer must sign where required. Authority commonly resides with senior regulatory, quality, or legal officers and should be documented to demonstrate signer attribution.

How common eSignature vendors compare for FDA Forms

Comparison of common eSignature vendors for signing and submitting FDA Forms; signNow appears first per vendor alignment and compliance features.

	signNow	DocuSign	Adobe Sign	PandaDoc	HelloSign
Starting Price	$8/user/mo	$15/user/mo	$14/user/mo	$19/user/mo	$15/user/mo
Free Trial	7-day free trial	Varies	Varies	Yes, limited	Yes, limited
Bulk Send	Yes	Yes	Yes	Yes	No
Audit Trail	Yes	Yes	Yes	Yes	Yes
HIPAA Compliant	Yes	Yes	Yes	No	No
Envelope Cap	No cap	100 envelopes/user/year	Varies	Varies	Varies

Electronic versus digital signatures — key contrasts

Key distinctions between electronic signatures and cryptographic digital signatures to guide FDA Form authentication and compliance decisions.

Criteria	Electronic Signature	Digital Signature
Definition	broad legal category	pki-based cryptographic method
Legal status	esign/ueta accepted	pki often required
Non-repudiation	audit trail evidence	cryptographic non-repudiation
Typical use	general filings	high-assurance regulatory

Security and compliance essentials for submission systems

Encryption: TLS 1.2/1.3 in transit; AES-256 at rest

Certifications: SOC 2 Type II; ISO 27001; PCI DSS

HIPAA: BAA available for covered entities

21 CFR Part 11: Compliant controls for FDA-regulated records

Audit Trail: Complete timestamps, IP, and action log

Accessibility: WCAG 2.0 Level AA compliance

Penalties and risks when FDA Forms are incorrect

Tax Filing Penalties: $60–$330+ per form under IRC §6721

Intentional Disregard: $660+ per form, no cap

I-9 Violations: $281–$2,789 per violation

Submission Rejection: Incomplete forms cause processing delays

Enforcement Action: Warning letters, fines, or recalls

Data Breach Risk: HIPAA/CCPA fines and remediation costs

Real examples of regulated organizations using eSign workflows

Two real-world examples show how secure eSignature workflows supported compliant submissions and streamlined signature collection for regulated organizations.

Optica Ventures

Optica Ventures needed a straightforward method to collect signatures from investors and service providers for regulatory acknowledgements.

Interface simplicity reduced signer friction.
Brian Fitzgibbons, COO, said: "The interface is simple and easy-to-use for our team; more importantly, it is just as easy for our customers." This helped accelerate form completion while preserving a clear audit trail for review.

Fertility Centers of Illinois

Fertility Centers of Illinois required reliable signed consent forms and API integration to streamline patient workflow across clinics and EMR systems.

API reliability and responsive support were decisive.
John Butler, Founder, praised the team's responsiveness and API, stating: "The airSlate SignNow team has been exceptional, responsive, the API has been great, and we're extremely happy that we chose airSlate SignNow as a company." Integration reduced manual retrieval and audit friction.

Practical best practices to reduce errors and delays

Follow these best practices to improve accuracy, speed, and compliance when preparing and submitting FDA Forms.

Verify Signatory Authority

Confirm the person signing is authorized by corporate delegation. Maintain a board resolution or delegation document and attach it when required to prevent challenges to signature validity.

Standardize Templates

Use validated, version-controlled templates with required fields locked. Templates reduce entry mistakes, ensure consistent wording for attestations, and speed batch processing for high-volume submissions.

Use Appropriate Authentication

Match authentication strength to risk: email-only for routine filings, KBA or SSO for high-assurance regulatory attestations. Document the chosen method to support auditability.

Preserve Complete Audit Trails

Retain signed document copies, access logs, timestamps, and IP addresses. Ensure records are reproducible to satisfy ESIGN retention and agency inspection requests.

Typical eSubmission workflow at a glance

A concise workflow for preparing, authenticating, and submitting FDA Forms electronically, including receipt confirmation and audit capture.

Upload: Add the finalized document to the platform.
Place Fields: Insert signature, date, and data fields for signers.
Authenticate: Confirm signer identity via email, SMS, KBA, or SSO.
Archive: Capture certificate of completion and store signed copies.

Integration and technical considerations for eSubmission

Common platform requirements and integrations to consider when enabling eSignature and eSubmission for FDA Forms include secure storage and certified audit trails.

Integrations: Salesforce, NetSuite, Google Workspace
Formats: PDF, DOCX, HTML supported
Authentication: Email, SMS, KBA, SSO options

Recommended workflow settings for FDA Forms

Suggested workflow settings when configuring an electronic FDA Form: authentication, file types, routing, and retention policies.

Field	Configuration
Authentication Level	Email link default; KBA or SSO for high assurance
File Types	PDF and DOCX preferred; preserve fonts and signatures
Bulk Send	Enable where mass distribution required; monitor usage
Audit Trail Retention	Retain signed audit logs for at least six years

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