Medical Device 510(k) Premarket Notification

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Understanding When a U.S. FDA 510(k) Clearance or Premarket Notification is Required: Navigating the Regulatory Pathway

The Food and Drug Administration (FDA) plays a crucial role in ensuring the safety and effectiveness of medical devices entering the U.S. market. One of the pathways through which manufacturers gain clearance for their devices is the 510(k) premarket notification. This process allows for clearance and subsequent marketing of medical devices based on their substantial equivalence to existing, legally marketed devices. In this article, we will delve into the intricacies of the FDA 510(k) premarket notification and explore how it facilitates the introduction of new medical devices into the market.

What is an FDA 510(k) Premarket Notification?

The FDA 510(k) premarket notification is a regulatory submission that device manufacturers must submit to the FDA before marketing a new medical device or making significant changes to an existing one. The name “510(k)” is derived from the section of the Food, Drug, and Cosmetic Act  (FDCA) that mandates this process. The primary purpose of the 510(k) notification is to demonstrate that the new or modified device is substantially equivalent to a legally marketed predicate device in terms of safety and effectiveness.

Each person who seeks to market in the U.S., a Class I, II, and III device intended for human use, and for which a Premarket Approval application (PMA) is not required, must submit a 510(k) to the FDA unless the device is exempt from 510(k) requirements under the FDCA and does not exceed the limitations of exemptions of the device classification regulation chapters. Prior to marketing a device, each submitter must receive an order, in the form of a letter, from FDA which finds the device to be substantially equivalent (SE) and states that the device can be marketed in the U.S., in other words, that the device is “cleared” for commercial distribution. The SE determination is usually made within 90 days and is made based on the information submitted by the submitter.

Please note that FDA does not typically perform 510(k) pre-clearance facility inspections. The submitter may market the device immediately after 510(k) clearance is granted. The manufacturer should be prepared for an FDA quality system (21 CFR 820) inspection at any time after 510(k) clearance. 


What are the Key Components of the 510(k) Submission?

Part 807 of the regulations describe the requirements and contents of a 510(k) submission. This includes the following:

  • Device Description

Manufacturers must provide a detailed description of the medical device, including its intended use, design, and technological features. Clear and comprehensive documentation is crucial for the FDA to assess the device’s safety and efficacy.

  • Predicate Device Comparison

A critical aspect of the 510(k) submission is the comparison between the new device and its predicate device. Manufacturers must identify a legally marketed device with similar intended use and technological characteristics, demonstrating that the new device is substantially equivalent.

  • Performance Data

Supporting data that validates the device’s safety and effectiveness may include laboratory testing, clinical studies, and other relevant information. This data is essential to establish the device’s substantial equivalence to the predicate and ensure its overall reliability.

  • Risk Analysis

Manufacturers are required to conduct a risk analysis, identifying and assessing potential hazards associated with the device. Mitigation strategies and risk management plans should also be included to demonstrate that the benefits of the device outweigh its risks.

  • Labeling

Accurate and clear labeling is crucial for healthcare professionals and end-users. The 510(k) submission should include labeling information that adheres to FDA requirements, providing instructions for proper device use and handling.

What is Substantial Equivalence?

A 510(k) requires demonstration of substantial equivalence (demonstration of safety and efficacy) to another legally U.S. marketed device (called a predicate device). The submitter must demonstrate that the predicate device has the same intended use and that any differences in technological characteristics do not raise different questions of safety and effectiveness. FDA utilizes scientific methods to assess differences in technological characteristics and performance data (e.g. clinical data and non-clinical bench performance data, including engineering performance testing, sterility, electromagnetic compatibility, software validation, biocompatibility evaluation and more).

Who is Required to Submit a 510(k)?

  • Domestic manufacturers introducing a device to the U.S. market (e.g. finished device manufacturers)
  • Specification developers introducing a device to the U.S. market (spec developers develop the specs for a finished device, but have the device manufactured under contract by another firm or entity)
  • Re-packers or re-labelers who make labeling changes or whose operations significantly affect the device
  • Foreign manufacturers/exporters or U.S. representatives of foreign manufacturers/exporters introducing a device to the U.S. market.

What are Pre-amendment Devices?

The term “preamendments device” refers to devices legally marketed in the U.S. by a firm, before May 28, 1976, and which have not been significantly changed or modified since then; and for which a regulation requiring a PMA application has not been published by FDA. FDA considers these devices “grandfathered” and as such, these devices do not require a 510(k) premarket notification.

What is the 510(k) FDA Review Process?

Once a 510(k) submission is received, the FDA reviews the documentation to determine whether the new device is substantially equivalent to the predicate device. The review process aims to ensure that the device meets the necessary safety and efficacy standards before entering the market. The FDA may request additional information or clarification during the review, which can extend the process. The SE determination is usually made within 90 days and is made based on the information submitted by the submitter.

Concluding Comments

The FDA 510(k) premarket notification process serves as a vital pathway for medical device manufacturers to introduce new products to the market efficiently. By demonstrating substantial equivalence to a legally marketed predicate device, manufacturers contribute to the FDA’s overarching goal of safeguarding public health. Navigating the regulatory landscape and complying with the 510(k) requirements are essential steps for companies seeking to bring innovative medical devices to patients while meeting stringent regulatory standards.

How Garg Law Can Help:

Whether you are a foreign or domestic device manufacturer, specification developer, component part manufacturer, re-packager, re-labeler, exporter, or other, Garg Law can assist you with determining your medical device compliance requirements, including whether 510(k) clearance is required prior to marketing the medical device in the U.S.  With our specific expertise in FDA medical device regulation, Garg Law can assist you with the following:

  • Assist foreign and domestic companies in identifying medical device compliance requirements and/or exemptions, as applicable
  • Develop regulatory strategy for the launch and marketing of a medical device, including assessment of FDA device classification, predicate devices, and testing requirements
  • Draft and file various requests for information and guidance from the FDA (e.g. 513(g) Request for Information, FDA Pre-Submission) as required.
  • Draft and file 510(k) premarket notifications with the FDA
  • Review and confirm compliance of device labeling
  • Assist with Quality Systems Regulation compliance
  • Assist with all other general and special controls compliance (e.g. S. FDA medical device establishment registration, including service as U.S. Agent for your foreign device establishment and renewal and updates to device establishment registration).
  • Represent and liaise with the appropriate FDA staff to resolve medical device compliance and enforcement matters

Garg Law’s expertise in medical device compliance enables you and your business to be on its way and one-step closer to marketing your medical device in the U.S., and ensuring FDA regulatory compliance.

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Key Contact
Shelly Garg counsel on FDA regulation
Shelly Garg

Scottsdale, AZ

(480) 565-2178
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