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513(g)

513(g) Request for Information: A Comprehensive Overview

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Introduction to FDA’s 513(g) Process

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The U.S. Food and Drug Administration (FDA) regulates medical devices to ensure their safety and effectiveness for patients and healthcare providers. The 513(g) Request for Information, named after Section 513(g) of the Food, Drug, and Cosmetic Act, is a regulatory mechanism that allows manufacturers or other stakeholders to seek FDA guidance on the classification and regulatory requirements for a medical device. This process is particularly useful when the classification of a device or the applicable regulatory pathway (e.g., 510(k), Premarket Approval (PMA), or De Novo) is unclear.

 

This page provides a thorough exploration of the 513(g) process, including its purpose, requirements, examples, benefits, challenges, and considerations for manufacturers, healthcare providers, and other stakeholders.

 

What is a 513(g) Request for Information?

 

A 513(g) Request for Information is a formal submission to the FDA to obtain clarification on the regulatory status of a medical device. This includes determining the device’s classification (Class 1, Class 2, or Class 3) and the appropriate regulatory pathway for market authorization. The 513(g) process is particularly valuable for novel devices, combination products, or devices with unclear predicates, where manufacturers need guidance to navigate the FDA’s regulatory framework.

 

The 513(g) process does not result in market clearance or approval but provides a non-binding FDA response that helps manufacturers plan their regulatory strategy. It is governed by 21 CFR Part 807, Subpart B, and is distinct from other premarket processes like 510(k) or PMA.

 

When to Use a 513(g) Request

 

Manufacturers may submit a 513(g) request in the following scenarios:

  • The device’s classification (Class 1, Class 2, or Class 3) is uncertain due to novel technology or unique intended use.

  • There is no clear predicate device for a 510(k) submission, and the manufacturer is unsure whether a PMA or De Novo pathway is required.

  • The device combines elements of multiple device types (e.g., a combination product with drug and device components).

  • The manufacturer seeks confirmation of whether the device is 510(k)-exempt or subject to Special Controls.

  • The device’s intended use or technological characteristics do not align with existing FDA classifications.

 

Regulatory Requirements for 513(g) Submissions

 

A 513(g) submission requires a concise but detailed dossier to enable the FDA to provide informed guidance. The submission must include sufficient information about the device to allow the FDA to assess its classification and regulatory requirements.

 

Key Elements of a 513(g) Submission

  1. Cover Letter:

    • A clear statement requesting 513(g) guidance.

    • Contact information for the manufacturer or submitter.

    • A brief overview of the device and the purpose of the request.

  2. Device Description:

    • A detailed description of the device, including its design, components, materials, and intended use.

    • Diagrams, schematics, or prototypes to illustrate the device’s functionality.

    • Information on whether the device is standalone or part of a system.

  3. Intended Use and Indications for Use:

    • A precise statement of the device’s intended use, including the patient population, medical condition, and clinical setting.

    • Any specific indications for use (e.g., diagnostic, therapeutic, or monitoring purposes).

  4. Proposed Classification (if applicable):

    • The submitter’s proposed classification (Class 1, Class 2, or Class 3) and rationale, if known.

    • Comparison to similar devices already classified by the FDA, if applicable.

  5. Regulatory History:

    • Any prior FDA interactions related to the device (e.g., Pre-Submission meetings or previous classifications).

    • Information on whether similar devices are marketed in the U.S. or internationally.

  6. Supporting Documentation:

    • Technical data, such as preliminary performance testing or bench studies.

    • Information on materials, software, or energy sources, if relevant.

    • For combination products, details on drug or biologic components.

  7. User Fee:

    • A 513(g) submission requires payment of a user fee, as mandated by the Medical Device User Fee Amendments (MDUFA). For fiscal year 2025, the standard fee is approximately $6,192 for small businesses and $24,770 for others (subject to annual adjustments).

    • Small businesses with gross receipts below the FDA’s threshold may qualify for a reduced fee.

 

Submission Process and Timeline

  • Submission: The 513(g) request is submitted to the FDA’s Center for Devices and Radiological Health (CDRH) via the electronic Submission Template and Resource (eSTAR) system or mail.

  • FDA Review: The FDA is required to respond within 60 days of receiving the submission, as mandated by statute. However, complex submissions or requests for additional information may extend this timeline.

  • FDA Response: The FDA provides a written response outlining:

    • The device’s classification (Class 1, Class 2, or Class 3).

    • Applicable regulatory requirements (e.g., 510(k), PMA, De Novo, or exemption status).

    • Relevant Special Controls, if applicable.

    • Guidance on next steps, such as preparing a 510(k) or PMA submission.

  • Non-Binding Nature: The FDA’s response is advisory and not legally binding. However, it provides valuable clarity for planning regulatory submissions.

 

Examples of Devices Requiring 513(g) Clarification

 

The 513(g) process is often used for novel or complex devices, such as:

  • Novel Diagnostic Tools: A new wearable sensor for monitoring a previously unaddressed biomarker, with no clear predicate.

  • Combination Products: A device that delivers a drug (e.g., a drug-eluting contact lens) where the primary mode of action is unclear.

  • Software-Based Devices: Software as a Medical Device (SaMD) with unique algorithms, such as AI-driven diagnostic tools.

  • Implantable Devices: A new type of bioresorbable implant with no existing predicate.

  • Hybrid Devices: A device combining diagnostic and therapeutic functions, requiring clarification on classification and regulatory pathway.

 

Benefits of the 513(g) Process

 

The 513(g) process offers several advantages for manufacturers and other stakeholders:

  • Regulatory Clarity: Provides clear guidance on the device’s classification and regulatory pathway, reducing uncertainty for novel or complex devices.

  • Strategic Planning: Helps manufacturers allocate resources effectively by identifying the appropriate premarket submission (e.g., 510(k), PMA, or De Novo).

  • Cost-Effective Guidance: Compared to preparing a full 510(k) or PMA submission without clarity, the 513(g) process is relatively low-cost and efficient.

  • Supports Innovation: Enables manufacturers of novel devices to navigate the regulatory landscape, fostering innovation in medical technology.

  • Early FDA Engagement: Facilitates early interaction with the FDA, building a foundation for future submissions or Pre-Submission meetings.

 

Challenges and Considerations for Manufacturers

 

While the 513(g) process is valuable, manufacturers face several challenges:

  • Limited Scope:

    • The 513(g) response is advisory and does not guarantee market clearance or approval.

    • It does not address detailed submission requirements (e.g., specific clinical trial designs), which may require additional FDA interactions.

  • Submission Preparation:

    • Preparing a comprehensive 513(g) submission requires detailed documentation, which can be challenging for novel devices with limited data.

    • Incomplete submissions may delay the FDA’s response or require additional information.

  • Cost Considerations:

    • The user fee, while lower than 510(k) or PMA fees, may still be a burden for small businesses or startups.

    • Additional costs may arise if further regulatory submissions are required based on the FDA’s response.

  • Timeline Variability:

    • While the FDA aims to respond within 60 days, complex devices or requests for additional information may extend the timeline.

  • Global Market Misalignment:

    • The 513(g) response applies only to U.S. regulations. Manufacturers targeting international markets must navigate additional standards, such as the European Union’s Medical Device Regulation (MDR) or ISO 13485.

 

Key Considerations for Stakeholders

 

The 513(g) process benefits various stakeholders, but certain considerations apply:

  • Manufacturers:

    • Use the 513(g) process early in device development to align regulatory strategy with FDA expectations.

    • Ensure the submission includes detailed and accurate information to avoid delays.

  • Healthcare Providers:

    • While 513(g) is primarily a manufacturer tool, providers developing custom devices (e.g., in-hospital 3D-printed implants) may use it to clarify regulatory requirements.

    • Understanding the 513(g) process can help providers advocate for novel devices in clinical settings.

  • Consumers:

    • The 513(g) process indirectly benefits patients by ensuring novel devices follow the appropriate regulatory pathway, enhancing safety and effectiveness.

    • Patients can inquire about a device’s regulatory status to ensure it has been evaluated by the FDA.

 

FDA Resources and Support

 

The FDA provides resources to assist manufacturers and other stakeholders with the 513(g) process:

  • 513(g) Guidance: Learn about the process at FDA’s 513(g) Request for Information.

  • Device Classification Database: Search for existing classifications at FDA’s Product Classification Database.

  • eSTAR Submission System: Access the electronic submission platform at FDA’s eSTAR Program.

  • User Fee Information: Check current 513(g) fees at FDA’s Medical Device User Fee Amendments.

  • Small Business Assistance: The FDA’s Division of Industry and Consumer Education (DICE) supports small manufacturers at FDA DICE.

  • Pre-Submission Program: For additional FDA feedback, consider a Pre-Submission meeting at FDA’s Pre-Submission Program.

 

Future Trends in the 513(g) Process

 

The 513(g) process is evolving to address advancements in medical technology and regulatory priorities:

  • Digital Health and AI: The rise of Software as a Medical Device (SaMD) and AI-driven devices has increased 513(g) submissions to clarify classification and regulatory pathways.

  • Combination Products: As devices increasingly combine with drugs or biologics, 513(g) requests help determine the primary mode of action and regulatory jurisdiction (e.g., CDRH vs. CDER).

  • Streamlined Processes: The FDA is improving electronic submission systems (e.g., eSTAR) to enhance efficiency and transparency for 513(g) requests.

  • Global Harmonization: Efforts through the International Medical Device Regulators Forum (IMDRF) may influence how 513(g) responses align with international regulatory frameworks.

  • Emerging Technologies: Innovations like 3D-printed implants, wearable sensors, and personalized medicine devices are driving increased use of 513(g) to address novel regulatory challenges.

 

Conclusion

 

The 513(g) Request for Information is a vital tool for manufacturers seeking clarity on the regulatory status of medical devices, particularly novel or complex technologies. By providing FDA guidance on device classification and regulatory pathways, the 513(g) process helps manufacturers plan effectively, reducing uncertainty and supporting innovation. While it does not grant market clearance, it serves as a critical step in navigating the FDA’s regulatory landscape, ultimately benefiting healthcare providers and patients by ensuring safe and effective devices.

 

For more information on the 513(g) process or to explore FDA regulations, visit the FDA’s Medical Devices page.

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