What Is a 510(k)?

‍Understanding the FDA’s Premarket Notification Pathway for Medical Devices

For most medical devices marketed in the United States, the first step toward FDA clearance is the 510(k) premarket notification. Named after section 510(k) of the Federal Food, Drug, and Cosmetic Act, this pathway allows manufacturers to demonstrate that their device is substantially equivalent to an existing legally marketed device—known as a predicate—in terms of safety and effectiveness.

For medical device companies, understanding how to prepare a clear, compliant 510(k) submission is essential to achieving timely market access.

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Why the 510(k) Pathway Matters

The 510(k) pathway remains the most common route to market for Class II and certain Class I medical devices. It provides an efficient mechanism for the FDA to evaluate new technologies without requiring the extensive clinical data demanded for Premarket Approval (PMA) submissions.

A well-prepared 510(k):

• Shortens the regulatory review cycle and reduces time to market

• Demonstrates substantial equivalence to a predicate device

• Establishes credibility and compliance with FDA expectations

• Reduces the likelihood of costly rejections or additional information requests

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Key Components of a 510(k) Submission

A successful 510(k) submission presents a clear, evidence-based argument that the new device is as safe and effective as its predicate. Typical components include:

1. Device Description
A detailed overview of the device design, materials, technological characteristics, and intended use.

2. Predicate Device Comparison
A side-by-side analysis highlighting how the subject device is substantially equivalent to a legally marketed predicate device.

3. Performance Data
Bench, analytical, and—if required—clinical testing results demonstrating that performance meets specifications and does not raise new safety or effectiveness concerns.

4. Labeling and Instructions for Use
All labeling must comply with 21 CFR Part 801, clearly communicating indications, contraindications, and intended use.

5. Risk Analysis and Design Controls
Evidence that the manufacturer’s quality system (per 21 CFR Part 820) identifies and mitigates potential risks through appropriate design controls.

6. Summary Reports and Declarations of Conformity
Applicable standards (e.g., IEC, ISO, ASTM) should be properly referenced with supporting documentation.

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510(k) Types

Depending on the nature of the device and its modifications, manufacturers may submit one of several types of 510(k):

• Traditional 510(k): The standard submission format used for most devices.

• Special 510(k): Streamlined submission for a device modification made by the same manufacturer that does not alter the intended use or fundamental scientific technology.

• Abbreviated 510(k): Utilized when FDA guidance documents or recognized standards can be used to demonstrate substantial equivalence. Submitted via the eSTAR template.

Choosing the correct submission type helps prevent unnecessary review delays.

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Common 510(k) Challenges

Even experienced teams can encounter obstacles, such as:

• Insufficient comparison or unclear rationale for predicate selection

• Incomplete or inconsistent testing documentation

• Poorly written summaries or labeling errors

• Gaps in verification and validation data

• Lack of alignment between engineering, quality, and regulatory teams

Early planning and expert review are critical to avoid Refuse-to-Accept (RTA) or Additional Information (AI) letters, which can significantly delay clearance.

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How GLOBAL Can Help

At GLOBAL, we support device manufacturers through every stage of the 510(k) process—from pre-submission strategy to final FDA clearance. Our experienced regulatory writers and consultants provide:

• Full 510(k) authoring and gap analysis aligned with FDA templates and expectations

• Predicate device research and substantial equivalence justification

• Performance testing documentation and summaries

• Labeling and risk management alignment with QMS requirements

• FDA communication support (and Notified Body support for EU submissions) and responses to AI requests

Whether you need targeted writing assistance or end-to-end regulatory guidance, GLOBAL helps ensure your submission is accurate, compliant, and review-ready.

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Partner With Experts Who Understand 510(k) Success

The 510(k) pathway may be well established, but success depends on precision and clarity. With deep experience across medical device categories and FDA submission types, our team at GLOBAL helps you bring safe, effective technologies to patients—faster and with confidence.

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Contact us today to learn how we can streamline your next 510(k) submission and position your product for regulatory success.

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