Who can sign the submission?

An authorized company official or delegated signatory should sign; ensure internal authority records or corporate resolution support the signer to prevent administrative challenges.

Can the package be submitted electronically?

Yes. Use FDA-accepted electronic submission methods and retain human-readable, exportable copies; 21 CFR Part 11 considerations may apply for electronic signatures.

What happens if FDA requests more data?

Respond with a focused, documented package addressing the specific request; attach cross-references and updated test reports to minimize back-and-forth.

Do clinical data always required?

Not always; the need for clinical data depends on device risk and predicate absence. Provide the minimal data necessary to demonstrate reasonable assurance of safety and effectiveness.

Should records be notarized?

Supporting corporate attestations sometimes require notarization depending on state law; check state notary and witness rules for signatures accompanying corporate documents.

How long should we retain submission records?

Keep submission packages and audit trails for several years after market removal; follow HIPAA, IRS, and applicable FDA record retention guidance.

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De Novo Request Form

De Novo Request Form

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De Novo Request Form--Arbitration

Civil Rule 16.1

IN THE SUPERIOR COURT OF THE STATE OF DELAWARE

COUNTY:

NEW CASTLE KENT SUSSEX

Plaintiff(s)

v.

Defendant(s)

:

C. A. No.:

DEMAND FOR TRIAL DE NOVO

Plaintiff(s)/Defendant(s), by their attorney, hereby request a trial de novo in the

above-captioned action, from the Arbitrator's Order of

A trial in the Superior Court is expected to last days.

By:

Attorney for:

DATED:

Attachment: Trial Fee

cc: Counsel & Pro Se Parties

Revised 8.21.03

What the De Novo Request Form Is

The De Novo Request Form is the formal submission used to ask the U.S. Food and Drug Administration (FDA) to classify a novel medical device into Class I or II when there is no legally marketed predicate device. A completed De Novo package explains the device, proposed indications for use, risk mitigation measures, and supporting data so FDA can assess reasonable assurance of safety and effectiveness. This guidance focuses on the U.S. regulatory process, required content types, electronic submission considerations, and how to assemble a clear, audit-ready filing.

Why a Correct De Novo Submission Matters

A clear, complete De Novo Request reduces review time and legal uncertainty by showing how benefits outweigh risks and proposing suitable controls. Proper documentation helps avoid administrative holds, additional information requests, and potential enforcement actions under the Federal Food, Drug, and Cosmetic Act.

Who Typically Prepares and Signs a De Novo Request

Final signatory authority should be documented internally and match the corporate power-of-attorney or delegated signatory policy used for other FDA submissions.

Regulatory Affairs teams managing submissions and communications with FDA.
Clinical or R&D leads compiling supporting performance and safety data.
Company executives or authorized signatories certifying statements and attestations.

Core Components to Include in a Professional De Novo Package

Assemble a concise, well-indexed package so reviewers can locate key items quickly; prioritize a clear summary, risk analysis, and essential test reports.

Cover Letter

Concise request describing device name, intended use, contact information, and regulatory classification requested; reference applicable FDA guidance and prior communications.

Device Description

Technical description of device components, materials, design, modes of operation, and proposed labeling sufficient to understand function and potential hazards.

Indications

Precise proposed indications for use and patient population; avoid ambiguous language that could broaden scope during review.

Benefit–Risk Analysis

Structured assessment identifying known/foreseeable risks, severity, and proposed mitigation measures such as labeling and performance testing controls.

Supporting Data

Bench, biocompatibility, electrical, software, and clinical data formatted with methods, results, and interpretation tied to safety claims.

Labeling & Instructions

Draft labeling, operator instructions, and warnings demonstrating how residual risks are communicated to users and clinicians.

Step-by-Step: Preparing and Submitting the De Novo Request

Follow a structured workflow from pre-submission checks through final folder assembly to avoid common administrative holds.

01

Pre-submission Review: Confirm intended device class and consult FDA guidance and pre-submission feedback when available.
02

Compile Evidence: Assemble bench, software, sterility, and clinical reports linked to claims.
03

Assemble Submission: Create a clearly indexed submission package with table of contents and cross-references.
04

Submit Electronically: Transmit using FDA eSubmitter or the specified electronic channel and retain the transmission receipt.

How the FDA De Novo Review Typically Progresses

Understanding the review stages helps you set realistic internal timelines and prepare for follow-up questions.

Administrative Acceptance: FDA confirms the package is complete enough to begin substantive review.
Substantive Review: Reviewers evaluate data, labeling, and proposed controls for reasonable assurance of safety and effectiveness.
Interactive Requests: FDA may issue additional information requests that must be answered promptly and clearly.
Classification Decision: FDA issues a classification order or requests further evidence prior to granting marketing authorization.

Digital Submission Settings and Recommended Configurations

Configure your e-submission environment to match FDA technical requirements and your internal review controls.

Field	Configuration
Submission Format	Use FDA-accepted electronic format (PDF/A preferred) and follow eSubmitter packaging rules.
File Naming	Use consistent names including document type, version, and date for traceability.
Access Controls	Limit edit rights; use version control and an approval workflow prior to submission.
Audit Trail	Capture timestamps, user IDs, and change history for each document and signature event.

Digital Signing and Platform Requirements

Verify platform compliance with 21 CFR Part 11 if records must meet FDA electronic-record/electronic-signature expectations; maintain exportable, human-readable copies.

File Formats: PDF, PDF/A, DOCX accepted for prepared content.
Authentication: Support for email, SMS, or stronger MFA.
Audit Trail: Immutable timestamps, IP, and signer attribution.

Penalties and Key Risks of an Incomplete or Incorrect Submission

Administrative Denial: FDA may refuse to classify without required evidence.

Review Delays: Incomplete responses trigger additional information requests and extend timelines.

Increased Costs: Repeat testing and rework raise project expenses.

Enforcement Action: Noncompliance can lead to warning letters or recalls.

Reputational Harm: Public regulatory issues affect market trust.

Commercial Impact: Delayed classification postpones market entry and revenue.

Typical Timeline Items and What to Expect

Timelines vary by submission complexity and FDA workload; build internal buffers for iterative questions and additional testing requests.

Pre-Submission Consultation:

Optional step to clarify expectations and scope before formal De Novo filing.

Administrative Screening:

Initial check for completeness before substantive review begins.

Substantive Review Window:

FDA conducts clinical and technical evaluation; expect interactive communications.

Additional Information Requests:

Respond promptly with clear documentation to avoid further delay.

Final Classification:

FDA issues a classification order or requests additional data prior to authorization.

Frequently Asked Questions — De Novo Request Form

Answers to common practical questions about preparing, submitting, and tracking a De Novo classification request.

Need help? Contact support

Who can sign the submission?
An authorized company official or delegated signatory should sign; ensure internal authority records or corporate resolution support the signer to prevent administrative challenges.
Can the package be submitted electronically?
Yes. Use FDA-accepted electronic submission methods and retain human-readable, exportable copies; 21 CFR Part 11 considerations may apply for electronic signatures.
What happens if FDA requests more data?
Respond with a focused, documented package addressing the specific request; attach cross-references and updated test reports to minimize back-and-forth.
Do clinical data always required?
Not always; the need for clinical data depends on device risk and predicate absence. Provide the minimal data necessary to demonstrate reasonable assurance of safety and effectiveness.
Should records be notarized?
Supporting corporate attestations sometimes require notarization depending on state law; check state notary and witness rules for signatures accompanying corporate documents.
How long should we retain submission records?
Keep submission packages and audit trails for several years after market removal; follow HIPAA, IRS, and applicable FDA record retention guidance.

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