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Manufacturers of Class II medical devices must receive FDA 510k approval before their product has the clearance to be sold in the United States.

Medical device companies that wish to sell their products in the United States are under the regulatory jurisdiction of the United States Food and Drug Administration (FDA). The FDA is responsible for authoring and enforcing the medical device quality system regulations (QSR), found in 21 CFR Part 820 of the Code of Federal Regulations. Under the FDA QSR, medical device companies who wish to sell their products in the United States must engage the pre-market approval process, with the specific pathway depending on the medical device's risk classification category.

FDA 510k approval is required for all non-exempt medical devices that fall into risk Class II. The FDA 510k approval process is the most common pre-market approval pathway for medical device companies, as data from the FDA shows that:

  • 35% of medical devices are in Class I, the lowest risk class, as they present minimal potential for harm to the end user. 93% of Class I devices are entirely exempt from the pre-market approval process.
  • 53% of medical devices are in Class II, most of which require FDA 510k approval
  • 9% of medical devices are in Class III, the risk class that presents the greatest potential risk to the end user. These devices can obtain pre-market approval from the FDA through the pre-market approval (PMA) process or the humanitarian device exemption (HDE)

What is an FDA 510k Submission?

Medical device companies are responsible for submitting a 510k form to the FDA whenever a premarket approval application (PMA) is not required, and unless the device is exempt from the 510k requirements of the Food, Drug and Cosmetic (FD&C) Act. The goal of an FDA 510k submission is to demonstrate that the device being brought to market is at least as safe and effective to another legally marketed medical device. This is also known as demonstrating "substantial equivalence".


What is Substantial Equivalence?

When a medical device company submits an FDA 510k form for review, their goal is to demonstrate substantial equivalence with a predicate device that is already on the market. The FDA defines specific criteria for substantial equivalence. A device is considered substantially equivalent to the chosen predicate device if it:

  • Has the same intended use as the chosen predicate device and
  • Has the same technological characteristics as the predicate device or
  • Has the same intended use as the chosen predicate device and
  • Has different technological characteristics and does not raise any different questions about safety and effectiveness and
  • The information submitted to the FDA demonstrates that the device is at least as safe and


To obtain an FDA 510k approval, your medical device company must choose a predicate device that either has the same intended use and technological characteristics as your new device, or you must choose a predicate device with the same intended use as your device and demonstrate that your product is equally safe and effective for the user as the predicate device.

Obtaining FDA 510k Approval

Medical devices marketed in the United States must either be cleared or approved by the FDA, unless they are exempt from the pre-market approval process.

Cleared medical devices are those that have been determined to be substantially equivalent to another legally marketed device through the FDA 510k pre-market submission process.

An approved medical device means that the FDA has approved a PMA or HDE application for the device. These reviews are more detailed and require more evidence than 510k submissions due to the riskier nature of the devices involved.

Greenlight Guru Streamlines the FDA 510k Approval Process

In 21 CFR Part 807.87, the FDA outlines the required contents for an FDA 510k submission. The FDA 510k submission requirements include extensive technical documentation such as proposed labeling, sterilization and shelf life data, biocompatibility research, animal, clinical and bench performance testing and other technical evidence needed to establish substantial equivalence and earn the FDA 510k approval or clearance.

Medical device companies can take advantage of Greenlight Guru's medical device QMS software has a purpose-built document management workflow to help speed up reviews and approvals by keeping all records and procedures organized, up-to-date and always accessible to the right people. These and other features of the cloud-based platform make it easy for companies to establish substantial equivalence, achieve FDA 510k clearance and get products to market faster.


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