Documentation Required for Medical Device Applications

Introduction

When applying for medical device market authorization, various documents must be submitted to regulatory authorities. This article explains the documents required for FDA (Food and Drug Administration) premarket submissions, particularly focusing on 510(k) submissions, which represent the most common pathway for medical device clearance in the United States.

Understanding these documentation requirements is essential for manufacturers seeking to market medical devices in the U.S. market. The information provided here is based on FDA regulations (21 CFR Part 807) and current guidance documents as of January 2025.

Overview of the 510(k) Submission Process

A 510(k) submission, formally known as a Premarket Notification, is a regulatory submission made to FDA to demonstrate that a device to be marketed is substantially equivalent (SE) to a legally marketed device. The legally marketed device to which equivalence is drawn is commonly known as the “predicate device.”

Types of 510(k) Submissions

There are three types of 510(k) submissions:

Traditional 510(k): The most common submission type that can be used under any circumstance to seek marketing authorization through the 510(k) Program. This submission includes comprehensive performance testing data and a detailed substantial equivalence comparison.

Special 510(k): Also known as a “510(k) for device modification,” this streamlined pathway is available when modifications are made to a manufacturer’s own legally marketed device. The Special 510(k) program is intended for manufacturers making modifications to their own devices where the modifications do not affect the intended use or alter the device’s fundamental scientific technology. The review process typically follows a 30-day cycle.

Abbreviated 510(k): This submission type relies on FDA guidance documents, demonstration of compliance with special controls for the device type, or voluntary consensus standards to support substantial equivalence claims. While the Abbreviated 510(k) requires the same sections as the Traditional 510(k), manufacturers can supplement their submission with summary reports demonstrating conformity to recognized standards rather than providing complete test reports.

Electronic Submission Requirements

As of October 1, 2023, all 510(k) submissions (unless exempted) must be submitted as electronic submissions using the Electronic Submission Template And Resource (eSTAR). The eSTAR is a structured PDF template that facilitates the preparation of electronic submissions and serves as a guided submission preparation tool to improve submission consistency and enhance efficiency in the review process.

Electronic submissions are uploaded through the CDRH (Center for Devices and Radiological Health) Customer Collaboration Portal, which also provides near real-time submission status tracking. The CDRH Portal cannot receive eSTAR submissions that are larger than 4 GB total or have individual PDF attachments larger than 1 GB. For submissions exceeding these limitations, manufacturers must mail the electronic version to the CDRH Document Control Center.

Similarly, as of October 1, 2025, all De Novo classification requests must also be submitted electronically using eSTAR, unless exempted as noted in FDA guidance documents.

Required Documentation Sections

A Traditional 510(k) submission should contain the following sections, preferably in the sequence listed below. Even when certain sections may not apply to a specific device, it is recommended to retain the section headings in the listed sequence and note “Not Applicable” or “N/A” to facilitate efficient FDA review. The following sections outline the comprehensive documentation requirements.

1. Administrative Documents

Medical Device User Fee Cover Sheet (Form FDA 3601)

This form is required for all submissions subject to user fees under the Medical Device User Fee Amendments (MDUFA V). The cover sheet includes information about the submitter, establishment registration numbers, and user fee payment details. Small businesses may be eligible for reduced or waived fees through the Small Business Determination (SBD) program.

As of November 1, 2024, all Small Business Requests (SBR) must be submitted electronically through the CDRH Portal. Starting August 1, 2025 (for Fiscal Year 2026 and later), all SBRs require Form 3602N, which replaces previous Forms 3602 and 3602A for both U.S. businesses and businesses headquartered outside the U.S.

CDRH Premarket Review Submission Cover Sheet (Form FDA 3514)

This voluntary form provides basic administrative information for premarket notification submissions. It includes:

• Establishment registration and listing information
• Device identification (product code, classification, regulation number)
• Predicate device information
• Declaration of conformity to recognized consensus standards
• Contact information for the official correspondent
• Certification statements regarding establishment inspection and truthful/accurate submission content

510(k) Cover Letter

The cover letter should provide an executive-level summary of the submission, including the device name, intended use, and key points of the substantial equivalence determination.

2. Device Identification and Classification

Indications for Use Statement

This critical section describes the general purpose of the device and the patient population for whom the device is intended. The indications for use must be clearly stated and will be compared directly to the predicate device’s indications. The FDA Form 3881 “Indications for Use” page is built into the eSTAR template.

The indications for use should specify:

• The general disease or condition the device will diagnose, treat, prevent, cure, or mitigate
• The patient population (age, gender, or other demographic information, if relevant)
• The part of the body or type of tissue with which the device interacts
• The frequency of use
• Other relevant information about the device’s use

Device Description

This section should include both a narrative description and a physical/technical description of the device. The narrative description should cover:

• Principles of operation
• Power source
• Device composition (materials)
• Physical characteristics (dimensions, weight)
• All models and variations to be marketed
• All accessories and components

The physical description may include labeled diagrams, photographs, engineering drawings, schematics, and other visual aids to fully characterize the device. For devices with patient-contacting components, a list of all such components and their respective materials should be provided.

Performance specifications should be described, including a brief description of the device design requirements. Engineering drawings should address the name and function of all parts, both internal and external, assembled and unassembled, and any interchangeable components.

3. Substantial Equivalence Comparison

Substantial Equivalence Discussion

This is the core of the 510(k) submission. Manufacturers must demonstrate that their device is substantially equivalent to a legally marketed predicate device by comparing:

Intended Use: The subject device must have the same intended use as the predicate device. Intended use refers to the general purpose or function of the device, determined by reviewing the proposed labeling and indications for use.

Technological Characteristics: A comparison table is recommended that specifically calls out:

• Design features and specifications
• Materials
• Energy source
• Operating principles
• Performance characteristics

The devices do not need to be identical. The key is demonstrating that any differences in technological characteristics do not raise different questions of safety or effectiveness and do not affect the device’s safety or effectiveness.

When technological characteristics differ, manufacturers must provide appropriate descriptive information and performance data (bench testing, animal studies, or clinical studies) demonstrating that the new device is as safe and effective as the predicate device.

Predicate Device Selection

A legally marketed device can be:

• A device legally marketed prior to May 28, 1976 (preamendments device)
• A device reclassified from Class III to Class II or I
• A device found substantially equivalent through the 510(k) process
• A device granted marketing authorization via the De Novo classification process

The predicate device cannot be one that is in violation of the Federal Food, Drug, and Cosmetic Act or has been recalled or withdrawn from the market for safety or effectiveness reasons.

4. Standards and Special Controls

Compliance with Standards and Regulations

Manufacturers must address compliance with:

• FDA special controls (specified in 21 CFR 800-892 for the specific device type)
• FDA mandatory performance standards (21 CFR 898 – only one such standard exists for electrode lead wires and patient cables)
• Standards under the Radiation Control for Health and Safety Act (RCHSA), if applicable
• Voluntary consensus standards recognized by FDA

When claiming substantial equivalence to devices that meet specific standards, the subject device should meet the same standards.

Declaration of Conformity to Recognized Consensus Standards

Manufacturers may submit a Declaration of Conformity (DOC) to FDA-recognized consensus standards. The FDA maintains a searchable database of recognized consensus standards on its website, which is updated even before formal recognition occurs through Federal Register publication.

When using FDA-recognized consensus standards, manufacturers should:

• List the standards in the CDRH Premarket Review Submission Cover Sheet (Form FDA 3514)
• Provide a DOC for each standard
• Include supplemental documentation as needed, particularly when the standard describes test methods but does not include acceptance criteria

Common FDA-recognized standards for medical devices include:

• ISO 14971: Application of risk management to medical devices
• ISO 10993 series: Biological evaluation of medical devices
• IEC 60601-1 and collateral standards: Medical electrical equipment safety
• IEC 62304: Medical device software lifecycle processes
• ISO 13485: Quality management systems for medical devices (recognized under MDSAP but not for use in standard premarket submissions)

Conformity with FDA-recognized standards can facilitate the premarket review process by reducing the amount of supporting testing documentation typically needed. However, manufacturers should note that adherence to a standard may not be sufficient alone for FDA to make a regulatory decision, and additional data may be requested.

5. Performance Testing Documentation

Bench Testing (Non-Clinical Performance Testing)

Manufacturers must describe bench testing and provide results that support the performance characteristics of the device. All submissions should include:

Test Protocols: Detailed test methods, acceptance criteria, sample sizes, and statistical analysis methods. Test protocols should be developed prior to testing and should reference relevant consensus standards where applicable.

Test Results: Complete test reports including raw data, data analysis, and comparison to acceptance criteria. Results should demonstrate that the device performs according to its specifications and is substantially equivalent to the predicate device.

Summary and Conclusions: An assessment of the test results and how they support the substantial equivalence determination.

Common types of bench testing include:

• Mechanical testing (tensile strength, fatigue, durability)
• Functional performance testing
• Shelf life and stability testing
• Package integrity testing
• Sterilization validation (for devices labeled sterile)

The FDA guidance document “Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions” provides detailed recommendations for presenting bench testing information.

Animal Studies (if conducted)

If animal testing was conducted, manufacturers should describe the tests and provide results supporting the device’s performance characteristics. All animal study documentation should include:

• Study protocol with objectives, methods, and endpoints
• Institutional Animal Care and Use Committee (IACUC) approval documentation
• Test results with statistical analysis
• Discussion of how results support substantial equivalence
• Compliance with Good Laboratory Practice (GLP) requirements, where applicable

Clinical Studies (if conducted)

For devices requiring clinical data to support substantial equivalence, manufacturers must provide:

• Clinical protocol identifying the study design, objectives, endpoints, patient population, and statistical analysis plan
• Institutional Review Board (IRB) approval documentation
• Informed consent forms
• Clinical study report including patient accountability, adverse events, and efficacy results
• Statistical analysis and clinical conclusions

The FDA guidance document “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]” Section F provides information on when clinical performance data may be required to support a substantial equivalence determination.

6. Biocompatibility

For devices with components that have direct or indirect contact with patients, manufacturers must evaluate the biocompatibility of patient-contacting materials according to ISO 10993-1 “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.”

Biocompatibility documentation should include:

• Identification of all patient-contacting materials
• Nature, degree, frequency, and duration of patient contact
• Biological safety risk assessment
• Testing performed (cytotoxicity, sensitization, irritation, systemic toxicity, etc.)
• Test reports and conclusions
• Justification for any testing not performed

For devices with a history of safe use or those using materials previously demonstrated to be biocompatible in similar applications, manufacturers may provide a biocompatibility rationale based on existing data rather than conducting new testing.

7. Software Documentation

For devices containing software, manufacturers must provide software documentation as described in the FDA guidance “Content of Premarket Submissions for Device Software Functions.” The documentation level depends on the software’s Level of Concern (Minor, Moderate, or Major), which is determined by the severity of harm that could result from device failure or software defect.

Required software documentation includes:

Software Description: Overview of the software, including operating environment, programming languages, development methodology, and any off-the-shelf (OTS) software components.

Device Hazard Analysis: Risk analysis identifying potential hazards related to software failures, including both random hardware failures and systematic software errors. This should follow the ISO 14971 risk management framework.

Software Requirements Specification (SRS): Functional and performance requirements, including user interface requirements, data definitions, and security requirements. Requirements should be traceable to design specifications and verification testing.

Architecture Design Chart: High-level software architecture showing major components, interfaces, and data flow.

Software Design Specification: Detailed design documentation proportional to the Level of Concern. Major Level of Concern devices require more comprehensive documentation than Minor Level of Concern devices.

Verification and Validation Documentation: Evidence that the software meets its specifications (verification) and fulfills its intended use (validation). This includes:

• Unit, integration, and system testing
• Traceability matrix linking requirements to tests
• Software version and revision information
• Validation testing in the intended use environment

Cybersecurity Documentation: As initiated in FY23 and continued through 2024-2025, FDA requires comprehensive cybersecurity information in premarket submissions, even when the submission is for a change that does not directly affect cybersecurity. This includes:

• Cybersecurity risk assessment and management
• Security architecture and controls
• Software Bill of Materials (SBOM)
• Vulnerability management plan
• Security update and patch management
• Documentation of secure development practices

The FDA guidances “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (2023) and “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations” (January 2025) provide current recommendations for cybersecurity and AI/ML-enabled device software documentation.

For AI/ML-enabled devices, manufacturers should also refer to the December 2024 guidance “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions,” which provides recommendations for including predetermined change control plans in marketing submissions.

The IEC 62304 “Medical device software – Software life cycle processes” standard is recognized by FDA and provides an excellent framework for the entire medical device software lifecycle incorporating a risk-based approach throughout.

8. Electromagnetic Compatibility and Electrical Safety

For devices with electronic components, manufacturers must evaluate electromagnetic compatibility (EMC) and electrical safety. This section should include:

EMC Testing: Evaluation of both emissions (interference with other electronic products) and immunity (susceptibility to interference from other electronic products). Testing should follow recognized consensus standards such as:

• IEC 60601-1-2: Medical electrical equipment – EMC requirements and tests
• CISPR 11: Electromagnetic compatibility for industrial, scientific, and medical equipment

Electrical Safety Testing: Evaluation according to recognized safety standards such as:

• IEC 60601-1: Medical electrical equipment – Basic safety and essential performance
• IEC 61010-1: Safety requirements for electrical equipment for measurement, control, and laboratory use (for laboratory devices)

Documentation should include:

• Test reports demonstrating compliance with applicable standards
• Risk assessment of electromagnetic hazards
• Labeling and instructions addressing EMC considerations
• Any special installation or use requirements related to electromagnetic environment

9. Sterility and Shelf Life

Sterility Documentation (for devices labeled sterile)

Manufacturers must provide:

• Sterilization method and parameters
• Sterilization validation reports according to recognized consensus standards:
  • ISO 11135: Ethylene oxide sterilization
  • ISO 11137: Radiation sterilization
  • ISO 17665: Moist heat sterilization
• Sterility assurance level (SAL) documentation, typically 10^-6
• Package integrity testing demonstrating maintenance of sterility throughout shelf life
• Residual analysis (e.g., ethylene oxide residuals for EtO-sterilized devices)

The FDA guidance “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile” (January 2024) provides current recommendations.

Shelf Life Documentation

For all devices with a defined shelf life, manufacturers must provide:

• Real-time or accelerated aging studies
• Package integrity testing at end of shelf life
• Functional performance testing at end of shelf life
• Testing protocol and acceptance criteria
• Statistical justification for sample sizes
• Stability data supporting the proposed shelf life

10. Labeling

The proposed labeling section should include all labeling that will be used with the device, pulled directly from design outputs. Labeling includes:

Device Label: All information appearing on the device itself and its immediate container.

Instructions for Use (IFU): Comprehensive instructions for device preparation, operation, cleaning, maintenance, and disposal. The IFU should address all aspects of safe and effective device use.

Package Insert: Information provided with the device, including indications for use, contraindications, warnings, precautions, and adverse events.

Patient Labeling: Any information provided to patients, including patient brochures or information cards.

Labeling must comply with 21 CFR Part 801 and should not include any promotional or marketing materials. All labeling should be truthful, not misleading, and adequate to ensure safe and effective use of the device.

Special attention should be given to:

• Warnings and contraindications
• Adequate directions for use
• Identification of device and manufacturer
• Sterilization status (if applicable)
• Symbols requiring explanation in the IFU (per ISO 15223-1)

11. 510(k) Summary or 510(k) Statement

Manufacturers must include either a 510(k) Summary or 510(k) Statement:

510(k) Summary: A detailed summary that will be made publicly available on the FDA website after clearance. The summary should include:

• Device name and classification
• Predicate device identification
• Device description
• Comparison table of technological characteristics
• Summary of testing performed
• Conclusions regarding substantial equivalence

510(k) Statement: A statement that the submitter will make safety and effectiveness information available to any person within 30 days of a written request. If a 510(k) Statement is provided instead of a 510(k) Summary, detailed information will not be publicly posted by FDA.

Most submitters choose to provide a 510(k) Summary as it demonstrates transparency and may support marketing efforts. When using eSTAR, manufacturers can choose to use the built-in 510(k) Summary template within eSTAR, eliminating the need to provide a separate 510(k) Summary document.

Additional Considerations and Special Circumstances

Combination Products

For devices that also contain drugs, biologics, or both, manufacturers should consult FDA’s combination product guidance documents. The lead center (CDRH, CBER, or CDER) will be determined based on the primary mode of action.

Third Party Review Program

Certain Class II devices eligible for the Third Party Review Program may be submitted to FDA-recognized third parties for review instead of submitting directly to CDRH. This program can potentially reduce review times for eligible devices.

Pre-Submission Meetings (Q-Submissions)

Before submitting a 510(k), manufacturers are encouraged to consider requesting a Pre-Submission meeting with FDA to discuss:

• Appropriateness of predicate device(s)
• Test protocols and acceptance criteria
• Clinical study design (if applicable)
• Substantial equivalence strategy
• Regulatory pathway confirmation
• Predetermined change control plans for AI/ML-enabled devices

The FDA guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program” provides detailed information on the Pre-Submission process. Pre-Submissions are submitted through eSTAR and tracked via the CDRH Portal.

Quality Management System Considerations

While not submitted as part of the 510(k), manufacturers must maintain design control documentation and quality management system records. The holder of a 510(k) must have design control documentation (per 21 CFR 820.30) available for FDA review during site inspections.

As of February 2, 2026, the FDA’s new Quality Management System Regulation (QMSR) becomes effective, incorporating by reference ISO 13485:2016 “Medical devices – Quality management systems – Requirements for regulatory purposes.” Until then, manufacturers must comply with the existing Quality System (QS) regulation in 21 CFR Part 820.

Submission Process and Review Timeline

Electronic Submission via CDRH Portal

Submissions are uploaded to the CDRH Portal, which provides:

• Secure submission upload
• Real-time submission status tracking
• Electronic correspondence from FDA
• Access for official correspondents and designated delegates

Submissions received before 4 PM ET on a business day will be processed the same day. Submissions received after 4 PM ET will be processed the next business day.

FDA Review Process

By Day 15 – Acceptance Review: FDA conducts an administrative review to ensure the submission is complete. If the submission is incomplete, FDA will place it on a “Refuse to Accept” (RTA) hold and notify the submitter of the deficiencies. Submitters have 180 days to respond to RTA deficiencies.

By Day 60 – Substantive Review: FDA conducts a detailed technical and scientific review. If additional information is needed, FDA will issue an “Additional Information” (AI) request. Most submissions receive at least one AI request.

By Day 90 – Final Decision: FDA issues a final decision letter. For substantially equivalent devices, FDA issues a “Substantial Equivalence” (SE) letter clearing the device for marketing. For devices not found substantially equivalent, FDA issues a “Not Substantially Equivalent” (NSE) letter.

The 90-day review goal represents FDA’s target under MDUFA V commitments. Actual review times vary based on submission complexity and the number of AI requests required.

Post-Clearance Requirements

After receiving 510(k) clearance, manufacturers must:

• Register their establishment with FDA (if not already registered)
• List the device with FDA
• Comply with all post-market requirements including:
  • Medical Device Reporting (MDR) – 21 CFR Part 803
  • Corrections and removals reporting – 21 CFR Part 806
  • Quality management system requirements
  • Establishment inspection preparedness
  • Adverse event reporting

Conclusion

Successful preparation of a 510(k) submission requires thorough understanding of FDA requirements, careful attention to detail, and comprehensive documentation of the device’s design, testing, and substantial equivalence to predicate devices. The documentation described in this article represents the minimum required information for most Traditional 510(k) submissions, though additional information may be required depending on the specific device type and technology.

Manufacturers should always consult device-specific guidance documents when available, as these provide detailed recommendations tailored to particular device types. The FDA also offers numerous educational resources through CDRH Learn and the Division of Industry and Consumer Education (DICE) to support manufacturers throughout the submission process.

The transition to mandatory electronic submissions via eSTAR represents FDA’s commitment to modernization and efficiency in the review process. By following the structured approach outlined in this article and utilizing FDA’s recognized consensus standards where appropriate, manufacturers can improve the quality and completeness of their submissions, potentially reducing review times and facilitating successful market clearance.

As regulatory requirements continue to evolve, particularly in areas such as cybersecurity, AI/ML-enabled devices, and quality management systems, manufacturers should regularly consult FDA guidance documents and the CDRH website for the most current recommendations and requirements.

Note: This article reflects FDA requirements and guidance documents current as of January 2025. Manufacturers should always verify current requirements by consulting the FDA website and relevant guidance documents, as regulatory requirements may be updated periodically.