Definition
Manufacturers of Class II medical devices must receive 510k clearance from FDA before their product can be legally sold in the United States.
510k clearance is required for all non-exempt medical devices that fall into risk Class II. The 510k clearance process is the most common pre-market pathway used by medical device companies to legally sell products in the US, 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 510k process.
- 53% of medical devices are in Class II, most of which require 510k clearance from FDA
- 9% of medical devices are in Class III, the risk class that presents the greatest potential risk to the end user. These devices must obtain pre-market approval from the FDA through the pre-market approval (PMA) process or the humanitarian device exemption (HDE)
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 in a marketing pathway process, with the specific pathway depending on the medical device's risk classification category.
What is an FDA 510k Submission?
Medical device companies are responsible for submitting a 510k notification 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 a 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?
To obtain 510k clearance, a medical device company must choose a predicate device that either has the same intended use and technological characteristics as your new device, or must choose a predicate device with the same intended use as their device and demonstrate that their product is equally safe and effective for the user as the predicate device.
When a medical device company submits an FDA 510k notification 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, which a manufacturer must show in order to receive 510k clearance. 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 effective for the user as the predicate device.
Obtaining 510k Clearance from FDA
Medical devices marketed in the United States must either be cleared or approved by the FDA, unless certain exemptions apply.
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 510k Clearance 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 receive FDA 510k 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, clearances, 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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