September 17, 2025

Why Section 513(g) Matters

For medical device companies entering the U.S. market, one of the biggest early challenges is understanding how the FDA will classify their device and what regulatory pathway applies.

To address this, the U.S. Food and Drug Administration provide a formal mechanism under Section 513(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

A 513(g) Request for Information allows manufacturers, startups, consultants, and importers to obtain FDA’s official feedback on:

  • Device classification (Class I, II, or III) 
  • Applicable regulatory pathway (e.g., 510(k), PMA, De Novo, or exemption) 

By law, the FDA aims to respond within 60 calendar days, making it a valuable tool for early regulatory clarity and risk reduction.

What Is Section 513(g)?

Section 513(g) is a formal written request submitted to the FDA seeking guidance on how a medical device will be regulated.

Unlike informal discussions or Q-Sub meetings, a 513(g):

  • Provides non-binding but official FDA feedback 
  • Helps confirm classification and regulatory expectations
  • Can be used before significant investment in development or submission preparation 

It is particularly useful when:

  • The device is novel or lacks a clear predicate 
  • Classification is uncertain or ambiguous 
  • Multiple regulatory pathways may apply 

FDA Device Classification Basics

Under the FD&C Act, devices are categorized based on risk level and regulatory controls:

Class I – Low Risk

  • Subject to general controls 
  • Often exempt from premarket submission 
  • Examples: bandages, examination gloves, tongue depressors 

Class II – Moderate Risk

  • Subject to general + special controls 
  • Typically require 510(k) clearance 
  • Examples: infusion pumps, contact lenses, pregnancy test kits 

Class III – High Risk

  • Require Premarket Approval (PMA) 
  • Strictest regulatory requirements 
  • Examples: implantable pacemakers, heart valves, deep brain stimulators 

Devices not marketed before May 28, 1976, are generally classified as Class III, unless they demonstrate substantial equivalence to an existing device.

Before Submitting a 513(g): Use FDA Resources

A 513(g) request involves user fees, so it’s often wise to first explore publicly available FDA tools:

  • FDA Product Classification Database 
  • 510(k) Database 
  • PMA Database 
  • De Novo Database 
  • FDA Guidance Documents 

These resources can help identify similar devices, predicates, and likely classifications, potentially eliminating the need for a formal request.

Submitting a Section 513(g) Request – Step by Step

1. What to Include

A complete and well-prepared submission should contain:

Cover Letter

  • Device name 
  • Submission date 
  • Specific regulatory questions 
  • Company and contact details 
  • Authorized signature 

Device Description

  • Materials, design, and components 
  • Dimensions and technical specifications 
  • Energy source (if applicable) 
  • Comparison of similar or predicate devices 
  • Diagrams, drawings, or photographs 

Intended Use

  • Target condition or disease 
  • Body part or system affected 
  • Patient population (adult, pediatric, etc.) 
  • Frequency and duration of use 
  • Prescription (Rx) or over the counter (OTC) 

Labeling / Promotional Material

  • Draft labeling (if available) 
  • Instructions for use (IFU) 
  • Comparable competitor labeling 

2. How to Submit

The FDA recommends electronic submission formats:

  • CDRH Portal – for most medical devices 
  • Electronic Submission Gateway (ESG)
  • CBER submission routes – for biologics-related devices 

Ensure the submission complies with FDA eCopy and formatting requirements.

3. FDA Response – What You Receive

Within ~60 days, the FDA provides:

  • Device classification (Class I, II, or III) 
  • Applicable regulatory pathway (510(k), PMA, De Novo, or exemption) 
  • Relevant guidance documents and standards 
  • Additional regulatory considerations (e.g., radiation safety, special controls) 

While informative, it’s important to note that 513(g) responses are advisory and not legally binding.

Why Section 513(g) Is a Strategic Advantage

Using a 513(g) request early in development can significantly improve outcomes:

Key Benefits

  • Regulatory Clarity
    Avoid uncertainty around classification and pathway 
  • Cost Savings
    Prevent incorrect submissions and rework 
  • Faster Market Entry
    Align development with the correct regulatory strategy 
  • Risk Reduction
    Minimize chances of FDA deficiencies, delays, or warning letters 
  • Investor Confidence
    Demonstrates a well-defined regulatory pathway 

When Should You Use 513(g)?

A 513(g) request is especially valuable when:

  • Developing a novel or innovative device 
  • Entering the U.S. market for the first time 
  • Facing unclear or conflicting classification information
  • Planning regulatory strategy for investors or partnerships

Limitations to Consider

While useful, 513(g) requests have some constraints:

  • Responses are non-binding 
  • Limited interaction compared to Q-Submission (Pre-Sub) meetings 
  • Requires user fees 
  • Not suitable for detailed clinical or technical discussions

For deeper engagement, companies may consider Pre-Submission (Q-Sub) meetings instead.

Best Practices for a Successful 513(g)

  • Provide clear, concise, and complete device descriptions
  • Ask specific, well-structured questions 
  • Include comparisons to similar devices 
  • Ensure consistency between intended use and labeling 
  • Align submission with current FDA guidance documents 

A well-prepared request improves the quality and usefulness of FDA’s response.

Outlook: Increasing Regulatory Complexity

As medical technologies evolve especially in digital health, AI/ML, and combination products classification challenges are becoming more complex.

Regulators are expected to:

  • Increase reliance on risk-based classification frameworks
  • Expand guidance for emerging technologies 
  • Encourage early engagement with FDA 

Tools like 513(g) will continue to play a key role in early regulatory decision-making.

Why This Matters

Section 513(g) is more than a regulatory formality it is a strategic tool that helps companies:

  • Making informed development decisions 
  • Avoid costly regulatory missteps 
  • Accelerate time-to-market 
  • Ensure compliance from the outset 

In a competitive and highly regulated industry, early clarity equals long-term success.

How Maven Regulatory Solutions Supports You

Our Expertise:

  • 513(g) request preparation and submission 
  • Device classification and regulatory strategy 
  • 510(k), De Novo, and PMA pathway planning 
  • FDA interaction and submission support 
  • End-to-end lifecycle compliance 

Why Choose Maven:

  • Deep expertise in FDA device regulations 
  • Strategic, risk-based regulatory approach 
  • Experience across global markets 
  • Proven success in accelerating approvals 

Strengthening Your FDA Strategy

Launching a medical device in the U.S.?

Partner with Maven to:

  • Define the right regulatory pathway early 
  • Avoid costly delays and rejections 
  • Build a strong compliance foundation 

Conclusion

The FDA Section 513(g) Request for Information is a powerful tool for early-stage regulatory clarity in medical device development. By obtaining FDA’s perspective on classification and pathway, companies can align their strategy, reduce risks, and move forward with confidence.

As regulatory expectations continue to evolve, proactive engagement with the FDA starting with tools like 513(g) is essential for successful, compliant market entry.

FAQs

1. What is a 513(g) request?
A formal request to FDA for device classification and regulatory pathway information.

2. Is the FDA response binding?
No, it is advisory but highly informative.

3. How long does it take?
Typically within 60 calendar days.

4. Who can submit a 513(g)?
Manufacturers, consultants, importers, and startups.

5. Does it replace a 510(k) or PMA?
No, it only provides guidance not approval or clearance.

6. Is there a fee?
Yes, FDA charges a user fee for 513(g) requests.

7. When should I use it?
Early in development when classification or pathway is unclear.