September 17, 2025

What is Section 513(g)?

Section 513(g) of the FD&C Act allows medical device manufacturers, startups, consultants, and importers to ask FDA about:

  • The class of the device (Class I, II, or III)
  • The FDA regulatory pathway required (510(k), PMA, or exemption)

By law, the FDA must provide a written response within 60 days. This helps businesses avoid costly mistakes, stay compliant with FDA rules, and follow the right approval path.

FDA Device Classification Basics

The FD&C Act divides devices into three main classes based on risk level:

  • Class I – General controls (lowest risk, e.g., bandages, examination gloves, tongue depressors)
  • Class II – General + special controls (medium risk, e.g., contact lenses, infusion pumps, pregnancy test kits)
  • Class III – Premarket approval + strict controls (highest risk, e.g., implantable pacemakers, heart valves, deep-brain stimulators)

 Devices not marketed before May 28, 1976, are usually Class III, unless FDA finds them “substantially equivalent” to an existing product.

 How to Get Device Information without 513(g)

Before spending money on a formal 513(g) request, you can check FDA’s free tools:

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

These resources help you research similar devices and identify the likely classification.

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

1. What to Include in Your 513(g)

A complete submission should have:

  • Cover Letter with device name, date, questions, contact details, and signature
  • Device Description (materials, size, design, energy source, comparison with similar products, photos or drawings)
  • Intended Use (target condition, disease, body part, frequency, prescription/OTC, patient type)
  • Labeling or Promotional Material (draft labeling or competitor labeling if available)

2. How to Submit Your 513(g)

FDA recommends electronic submissions through:

  • CDRH Portal (for medical devices regulated by CDRH)
  • FDA ESG (Electronic Submission Gateway) or CBER email (for biologics-related devices)

3. What FDA Will Send Back

Within 60 calendar days, FDA provides:

  • Device classification (Class I, II, or III)
  • Regulatory requirements (PMA, 510(k), or exemption)
  • Any related FDA guidance documents
  • Other requirements (e.g., radiation safety regulations if applicable)

Why Section 513(g) Matters for Companies

Using Section 513(g) early in the product development process helps companies:

  • ? Get Clarity – Avoid confusion about device class and regulatory pathway
  • ? Save Money – Prevents wrong submissions and costly resubmissions
  • ? Faster Market Entry – Speeds up device FDA clearance or approval
  • ? Lower Risk – Reduces chances of FDA warning letters and compliance issues

Final Thoughts

The FDA Section 513(g) Request for Information is more than just a legal option—it is a business strategy for the medical device industry. By getting FDA’s direct input, companies can:

  • Avoid delays in FDA approval or clearance
  • Reduce compliance mistakes
  • Save time and money in the regulatory process
  • Build trust with investors, partners, and healthcare providers

 If you are launching a new medical device in the US, filing a 513(g) request is a smart first step to ensure success, safety, and compliance.