How to Fill Out FDA Form 3864 (w/Examples) + FAQs

FDA Form 3864 is the official form you use to request certification for a designated medical gas in the United States. Without this certification, selling medical gases like oxygen, nitrogen, or nitrous oxide for therapeutic purposes is illegal. Section 576 of the Federal Food, Drug, and Cosmetic Act creates this requirement. If you market a designated medical gas without a granted certification, the FDA considers your product an unapproved new drug—a violation that can result in warning letters, seizures, and injunctions.

Between 1996 and 2004, the FDA received reports of medical gas mix-ups resulting in at least 8 patient deaths and 16 serious injuries. The certification process exists to protect public health by ensuring gas manufacturers meet safety standards.

In this article, you will learn:

📋 Every field on FDA Form 3864 and exactly how to complete each section

⚠️ The specific mistakes that cause FDA rejections and how to avoid them

🏭 Who must file this form—and who should not file it

📅 Post-certification requirements including annual reports and adverse event reporting

💡 Real-world examples showing correct vs. incorrect submissions

What Is FDA Form 3864?

FDA Form 3864 is titled “Request for Certification of Designated Medical Gas.” The FDA created this form under Title XI of FDASIA (Food and Drug Administration Safety and Innovation Act of 2012). It provides a streamlined path to drug approval for specific medical gases.

A certification granted through Form 3864 gives your product an approved NDA (New Drug Application) number, NADA (New Animal Drug Application) number, or both. This deemed approval applies only to specific gases and specific medical uses listed in federal law. The certification process is much faster and cheaper than a traditional NDA submission.

The Seven Designated Medical Gases

Federal law identifies seven designated medical gases eligible for the Form 3864 certification process. Each gas has specific approved indications:

Carbon monoxide presents a special case. No USP or NF monograph currently exists for it. The FDA will not grant certifications for carbon monoxide until a compendial standard is established. However, the FDA does not object to its marketing for lung diffusion testing if it meets an acceptable alternative standard.

Who Must File Form 3864?

Not every company handling medical gases needs to file this form. The FDA requires certification only from the first person or entity that introduces a designated medical gas into interstate commerce for medical purposes.

Companies That Must File

The following entities must submit Form 3864:

Original Manufacturers — Companies that produce the gas through chemical reaction, physical separation, compression of atmospheric air, or other means and sell it for medical use

First Medical Marketers — Companies that purchase industrial-grade gas and reprocess it into a medical gas meeting USP/NF standards for the first time

Companies That Should NOT File

Downstream Distributors and Transfilllers — If you purchase medical gas from a certified source and redistribute it, you do not file Form 3864. Instead, you must verify your supplier has a granted certification.

Combination Gas Makers — If you combine two or more designated medical gases, you do not need separate certification for the combination. Each individual gas must have a certification, but medically appropriate combinations are covered automatically.

How to Fill Out Form 3864: Field-by-Field Instructions

The FDA strongly encourages electronic submission through the CDER NextGen Portal. Paper submissions require two copies mailed to: Central Document Room, 5901B Ammendale Road, Beltsville, MD 20705.

Section 1: Applicant Information

This section identifies who is requesting certification. Enter the legal name of the person or entity submitting the request.

Applicant Name (Required) — Use the exact legal name as registered with your state. Do not use trade names or DBA names here.

Applicant Address (Required) — Provide the complete mailing address including street, city, state/province, ZIP code, and country.

Contact Information — Include a contact person’s name, title, phone number, email address, and fax number. The FDA uses this information to communicate about your submission.

U.S. Agent Information — Foreign applicants must provide an authorized U.S. agent’s name and contact details. This agent handles FDA communications on your behalf. The agent must reside or maintain a place of business within the United States.

Example — Correct Entry:

Applicant Name: Mountain Air Medical Gases, LLC
Address: 1234 Industrial Parkway, Suite 100, Denver, CO 80202
Contact: Jane Smith, Regulatory Affairs Director
Phone: (303) 555-1234 | Email: [email protected]

Example — Incorrect Entry:

Applicant Name: Mountain Air (missing LLC designation)
Address: Denver, CO (incomplete—missing street address)

Section 2: Type of Submission

Check exactly one box to indicate your submission type. This determines how the FDA processes your request.

Original Certification Request — Select this for your first certification request for a particular gas. Choose whether you want:

• NDA only (human use)
• NADA only (animal use)
• Both NDA and NADA (human and animal use)

Amendment to Pending Certification Request — Select this if your original submission is still under FDA review and you need to provide additional information or corrections.

Resubmission — Select this if FDA previously denied your certification request and you are resubmitting after addressing the deficiencies.

Supplement to a Granted Certification — Select this to report changes to an already-certified gas (like new manufacturing facilities).

Other — Use this for submissions that do not fit other categories.

For any submission other than an original certification, you must include your assigned NDA and/or NADA number. The FDA assigns this number in your acknowledgment letter after receiving an original submission.

Reason for Submission — Provide a brief explanation if you selected anything other than “Original Certification Request.” Examples include:

• “Response to Information Request Letter dated 02/15/2026”
• “Notification of new manufacturing facility”
• “Change in applicant contact information”

Section 3: Description of Medical Gas

Select exactly one gas by checking the appropriate box. Each certification request covers only one gas. If you manufacture multiple designated medical gases, submit separate requests for each.

Critical Distinction: “Oxygen” vs. “Oxygen 93 Percent”

The USP contains two separate oxygen monographs. Only “Oxygen” (≥99.0% O₂) qualifies as a designated medical gas. “Oxygen 93 Percent” (90-96% O₂) is a different product produced by molecular sieve processes (like concentrators). Oxygen 93 Percent does not qualify for Form 3864 certification.

This same distinction applies to nitrogen. Only the “Nitrogen” NF monograph (≥99.0%) qualifies—not “Nitrogen 97 Percent.”

Section 4: Facility Information

List every facility where the designated medical gas is initially produced. Initial production means the first manufacturing step—chemical reaction, physical separation, purification from industrial grade, or compression of atmospheric air.

Facility Name (Required) — The full legal name of each manufacturing site

Facility Address (Required) — Complete physical address (not a P.O. Box)

D-U-N-S Number — The Data Universal Numbering System number assigned by Dun & Bradstreet. If your facility lacks one, obtain it free before submitting.

FEI Number — The FDA Establishment Identifier, if your facility already has one from prior FDA registration

Brief Description — Explain what manufacturing activities occur at each facility. Keep it concise but clear.

Good Examples:

“Production of oxygen by cryogenic air separation”
“Purification of industrial nitrogen to NF standards”
“Compression and filling of medical air”

Poor Examples:

“Manufacturing” (too vague)
“We make gas” (insufficient detail)

If you manufacture at multiple facilities, click “Add Continuation Page” on the electronic form. You need only one certification request per gas, even with multiple facilities or manufacturing methods.

Section 5: Certification Statement

Check the box to affirm that your “methods, facilities, and controls used for the manufacture, processing, packaging, and holding of the designated medical gas, as applicable, are adequate to preserve the safety, identity, strength, quality, and purity of the gas.”

This statement carries legal weight. You certify compliance with Current Good Manufacturing Practice (CGMP) requirements under 21 CFR Parts 210 and 211, and as of December 18, 2025, the new 21 CFR Part 213 specific to medical gases.

Section 6: Additional Information

This section is optional. Include any other information that may help FDA determine your gas is a designated medical gas. Examples include:

• Certificates of analysis showing compendial compliance
• Quality system documentation
• Special manufacturing circumstances

Section 7: Signature(s)

Applicant Signature (Required) — The person signing must be authorized to bind the company. Include printed name, title, signature, and date.

U.S. Agent Signature — Required only if the applicant does not reside or have a place of business in the United States. The agent countersigns to accept responsibility for U.S. communications.

The signature block includes a warning: “A willfully false statement is a criminal offense” under 18 U.S.C. § 1001. False statements can result in fines and imprisonment.

What Happens After You Submit Form 3864?

The FDA follows a specific timeline for processing certification requests. Understanding this timeline helps you plan your market entry.

The 60-Day Review Period

Your certification request is deemed granted unless FDA acts within 60 days of filing. The FDA can:

1. Grant the certification — You receive a letter with your NDA and/or NADA number
2. Request additional information — FDA may contact you to clarify or supplement your submission
3. Deny the certification — FDA must explain why

Reasons FDA May Deny Certification

Under Section 576(a)(2), the FDA can deny your request if:

• The gas is not a designated medical gas (does not meet compendial standards)
• The request lacks required information under Section 576(a)(1)
• The request lacks sufficient information to determine if the gas qualifies
• Denying the request is necessary to protect public health

Post-Certification Requirements

Obtaining certification is not the end of your regulatory obligations. Certified designated medical gases are subject to ongoing requirements.

Annual Reports

Under 21 CFR 230.80, you must submit annual reports within 60 days of the anniversary of your certification approval. The report must include:

• List of current facilities where the gas is initially produced
• List of facilities no longer in use
• Any changes to applicant information

Submit annual reports using Form FDA 5025 through the CDER NextGen Portal or by mail.

Field Alert Reports

If you discover a quality problem with distributed gas, you must submit a Field Alert Report within 3 days under 21 CFR 230.205. Reportable problems include:

• Labeling mix-ups
• Bacterial contamination
• Significant chemical or physical changes
• Failure to meet specifications

Adverse Event Reporting

For serious adverse events related to your designated medical gas, you must submit an Individual Case Safety Report (ICSR) to the FDA Adverse Event Reporting System (FAERS). Reports are due within 15 calendar days for serious events.

The designated medical gas regulations at 21 CFR 230.210 exempt certified gases from periodic safety reports since new safety issues with these well-established gases rarely emerge.

Three Common Scenarios with Examples

Scenario 1: Original Manufacturer Filing Initial Certification

Acme Gas Corporation produces oxygen through cryogenic air separation at two facilities. They want to sell to hospitals.

Outcome: If FDA does not act within 60 days, Acme receives deemed approval and an NDA number.

Scenario 2: Reprocessor Converting Industrial Gas to Medical Grade

GasTech Industries purchases bulk industrial nitrogen and purifies it to NF standards for medical distribution.

Outcome: GasTech becomes the NDA holder for this product line.

Scenario 3: Downstream Distributor

MedSupply Co. purchases certified oxygen from Acme Gas and transfills it into patient-size cylinders.

Outcome: MedSupply operates under Acme’s certification but must maintain verification records.

Mistakes to Avoid

The FDA has issued warning letters to medical gas manufacturers for serious violations. Avoid these common errors:

1. Failing to Conduct Identity Testing

Under CGMP regulations, you must test each batch of incoming gas for identity. You cannot rely solely on supplier certificates of analysis without validating their test results at appropriate intervals.

Consequence: The FDA may issue a warning letter and require you to conduct a retrospective evaluation of all distributed product.

2. Inadequate Release Testing

Before distributing any batch, you must perform full release testing including identity, strength (assay), and impurity testing. Skipping these tests means you have no scientific evidence your gas meets specifications.

Consequence: You may be distributing adulterated product that could harm patients.

3. Using the Wrong Compendial Standard

Selecting “Oxygen 93 Percent” instead of “Oxygen” or “Nitrogen 97 Percent” instead of “Nitrogen” disqualifies your gas from the certification process.

Consequence: Your certification will be denied. You would need a full NDA to market the product.

4. Failing to Calibrate Equipment

Equipment like oxygen analyzers and pressure gauges must be calibrated according to your procedures. One manufacturer received a warning letter for equipment not calibrated since November 2020.

Consequence: Test results are unreliable, and the FDA may question all product released during that period.

5. Poor Documentation Practices

FDA investigators found instances where employees documented test results without actually performing the tests or used incorrect equipment serial numbers. Every manufacturing and testing step must be documented at the time of performance by the person who conducted it.

Consequence: Data integrity violations are serious FDA findings that can result in regulatory action.

6. Weak Quality Unit Oversight

Your Quality Unit must review all raw data and completed records before batch release. Simply signing off without adequate review violates CGMP requirements.

Consequence: Adulterated product may reach patients.

Do’s and Don’ts for Form 3864

Do’s

✅ Do submit separate requests for each gas — One form per designated medical gas, even if manufactured at the same facility

✅ Do verify your gas meets the exact compendial standard — “Oxygen, USP” is different from “Oxygen 93 Percent, USP”

✅ Do obtain D-U-N-S numbers before submitting — Free from Dun & Bradstreet; required for each facility

✅ Do include a cover letter — Explain the submission type and reference any prior correspondence

✅ Do use the CDER NextGen Portal — Electronic submission is faster and preferred by FDA

Don’ts

❌ Don’t file if you’re a downstream distributor — Verify your supplier’s certification instead

❌ Don’t combine multiple gases on one form — Each gas requires its own certification request

❌ Don’t use trade names as your applicant name — Use your legal entity name

❌ Don’t ignore the 60-day window — If you receive an information request, respond promptly or risk denial

❌ Don’t falsify information — Criminal penalties apply under 18 U.S.C. § 1001

Labeling Requirements for Certified Medical Gases

Once certified, your gas must bear specific labeling under 21 CFR 201.161. Requirements include:

Warning Statements by Gas Type

Oxygen — Warning that uninterrupted use of high concentrations over long duration without monitoring may be harmful; oxygen should not be used on patients who have stopped breathing unless used with resuscitative equipment

Nitrogen, Carbon Dioxide, Helium, Nitrous Oxide — Warning that administration may be hazardous or contraindicated; should be used only by or under the supervision of a licensed practitioner experienced in its use

Emergency Oxygen Exception — For oxygen provided for emergency use without a prescription, the label must state: “Oxygen can be used for emergency use only; for all other medical applications a prescription is required.”

Key Entities and Their Roles

Understanding who is involved in medical gas regulation helps you navigate compliance requirements.

FAQs

Can I file Form 3864 for Oxygen 93 Percent produced by a concentrator?
No. Oxygen 93 Percent is a separate USP monograph and does not qualify as a designated medical gas under Section 575 of the FD&C Act.

Do I need to pay a user fee to submit Form 3864?
No. Under Section 360ddd-2, designated medical gases are exempt from prescription drug user fees that typically apply to NDAs.

Can I start selling my medical gas while my certification is pending?
No. Until certification is granted (or deemed granted after 60 days), your gas is an unapproved new drug and marketing it violates federal law.

Do I need both NDA and NADA numbers?
No. Request only what you need. If you sell exclusively for human use, request NDA only. Request both only if you market for human and animal use.

What happens if FDA does not respond within 60 days?
Yes, your certification is deemed granted automatically by law. FDA will issue a follow-up letter confirming the grant and providing your NDA/NADA number.

Can foreign manufacturers apply for certification?
Yes. Foreign applicants must designate a U.S. agent who resides or maintains a business in the United States to handle FDA communications.

Do I need to renew my certification annually?
No. Certification does not expire. However, you must submit annual reports and maintain drug establishment registration.

Can I use my supplier’s NDA number on my product listing?
Yes. Downstream distributors and transfilllers should use their certified supplier’s NDA number when listing their drug products with FDA.

Is carbon monoxide currently certifiable?
No. The FDA will not grant certifications until a USP or NF monograph is established. Marketing is tolerated under current enforcement discretion.

What if my certification is denied?
Yes, you can resubmit. Address all deficiencies identified in FDA’s denial letter and check “Resubmission” as your submission type.

Do combination products (gas + device) have different requirements?
Yes. If your medical gas includes a device component like a specialized valve, you must comply with 21 CFR Part 4 for combination products, with compliance required by February 2, 2026.

Does certification mean FDA has tested my gas?
No. Certification deems your application approved based on your representations. FDA may inspect your facility but does not test your product as part of certification.