510(k) Premarket Notification for Medical Devices

Many Class I and Class II medical devices are permitted to enter the U.S. market via the 510(k) premarket notification process.

Medical devices must be approved by the Food and Drug Administration (FDA) before they can be marketed to the public. The main method of gaining approval for a medical device from the FDA is a premarket approval (PMA). However, some devices don’t require a PMA. Devices that are similar enough to devices that are already on the market only require premarket notification, also known as a 510(k). 

The 510(k) is a much simpler, easier, and cheaper submission to make to the FDA, as it is not for a new and therefore potentially riskier technology, but rather for something the FDA has seen before and found to be safe. The 510(k) does still require that the device be shown to be as safe and effective as something already on the market. 

The Center for Devices and Radiological Health (CDRH) oversees the 510(k) premarket notification.

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History of the 510(k)

Since 1906 with the signing of the Pure Food and Drugs Act, the Food and Drug Administration has regulated the development and distribution of products designed for human consumption. Decades later, in 1976, an amendment to the Federal Food Drug and Cosmetic Act of 1938 was passed: The Medical Device Amendment. This amendment was designed to assure the public that a medical device was reasonably safe, and established the three-tier class system that is still used today. The Medical Device Amendment also instituted post market requirements for medical devices, such as Good Manufacturing Practices (GMP), listing devices with the FDA, and reporting adverse effects.

The 1990 Safe Medical Devices Act further added to the post market to-do list for 510(k) products. Facilities such as hospitals and nursing homes also gained the requirement to report adverse effects related to medical devices. The Act also defined substantial equivalence, which is the determining factor for whether or not a 510(k) premarket notification is approved.

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510(k) Submission Requirements

The major requirement for a 510(k) notification is that the product is “substantially equivalent” to an already approved product. The definition of “substantially equivalent” to a predicate product was confirmed in 1990 to be as follows:

• The new product has same intended use as the previously marketed device.
• The new product has the same technological characteristics as the predicate device, OR
• The new product has the same intended use as the predicate AND different technological characteristics as the predicate without raising different questions of safety and effectiveness AND the information submitted to the FDA demonstrates that the device is equally safe and effective as the predicate.

If the FDA provides a letter finding the new device substantially equivalent to the previous device, the new device may then be legally marketed.

A company has the following options if the device is not found to be substantially equivalent:

• The company may resubmit a new 510(k) with additional data supporting substantial equivalence.
• The company may go through the De Novo Classification process to try and receive Class I or Class II designation
• They can file a reclassification petition.
• The company may submit an application for premarket approval (PMA).

A lack of substantial equivalency does not mean the medical device can never be marketed, it just means that the FDA did not find the product to be similar enough to a device they had already approved, and therefore they need more data in order to determine whether it is safe and effective. Of course, that potentially means a significant amount of additional safety and efficacy data that would cost a lot of money. Therefore, most who submit a 510(k) would prefer to avoid having to submit a PMA.

An important consideration for a medical device is who must submit a 510(k). For a single device there could be multiple submissions, depending on the manufacturers. The following entities must submit 510(k) premarket notifications:

• U.S. manufacturers who are introducing a device to the U.S. market must file a 510(k). If a manufacturer is making the finished device based on their own specifications, they must submit a 510(k) in order to market it in the U.S. Any accessories for the device that are sold to the end user (as opposed to another manufacturer for assembly) also fall under the category of finished devices. Those manufacturing device components that are sold to another manufacturer for assembly do not have to file a 510(k), nor do contract manufacturers that are creating finished devices based on their customers’ specifications.
• Companies that are developing the specifications for a medical device that will be marketed in the U.S. must file a 510(k) for that device. The company may be having the device manufactured elsewhere, but it is the entity responsible for the specifications that must submit the premarket notification.
• If a company repackages or relabels a medical device and makes significant changes have to submit a 510(k) for the product. A significant change is one that affects the operation of the device, involves modification of manuals, adding a new intended use, changing warnings, adding contraindications, or any operation that could alter the device’s condition. Repackaging or relabeling that does not significantly change the labeling or operation of the device does not require a 510(k) submission.
• Manufacturers, exporters, or U.S. representatives of foreign manufacturers or exporters who want to bring a new device to the U.S. market must submit a 510(k) premarket notification.

In contrast, the following situations do not require the submission of a 510(k):

• An entity selling an unfinished product to another company that will finish the medical device or sell its components.
• A device that is not to be marketed or distributed commercially, such as during the development, evaluation, or testing of a new device. Devices being used in clinical trials are subject to the Investigational Device Exemption, but do not require a 510(k) as a prerequisite for trials to begin.
• Entities that are solely distributors of domestically manufactured medical devices do not need 510(k)s. A label that states the entity is the distributor is sufficient for legal reselling as long as the distributor does not significantly change the labeling or the product.
• If the device in question was legally commercially distributed before the Safe Medical Devices Act of 1976 and has not been significantly changed, it is considered to be “grandfathered” in and does not require a 510(k).
• For a device made outside the U.S., as long as a 510(k) was submitted by the foreign manufacturer and approved, the importer is cleared to market it.
• Some Class I and Class II medical devices are exempt from requiring a 510(k). These exempted devices can be found here: Medical Device Exemptions 510(k) and GMP Requirements. Exempt devices are still subject to limitations, so only those that remain within those limits do not require 510(k) premarket notification.

Other Applicable Requirements for Medical Devices

In order for any medical device to be marketed in the U.S. the FDA has a series of requirements designed to ensure their safety. These requirements are delineated in the Medical Device Amendments, and their applicability depends on the classification of the medical device in question.

Class I devices pose the least risk to human health. They are not meant to be life-sustaining or supporting, and can’t pose any unreasonable risk of injury or illness. Examples of Class I devices are Band-Aids and sterile gloves. Class I devices are required to adhere to General Controls as defined by the Medical Devices Act. General controls include parts of the Medical Devices Act that relate to adulteration; misbranding; device registration; premarket notification; banned devices; notification and repair, replacement and refund; records and reports; restricted devices; Good Manufacturing Practices (GMP). All medical devices must adhere to General Controls, though this is the only level of control required for Class I devices.

Class II devices pose a higher risk than Class I and therefore are subject to additional controls. The definition of a Class II device is one that requires these additional controls in order to maintain its safety. Called Special Controls, they include special labeling requirements, mandatory performance standards, and post market surveillance. Surgical robots, acupuncture needles, and powered wheelchairs are all Class II devices. Class II devices are also required to follow General Controls.

Class III devices are not eligible for the 510(k) pathway and instead must seek premarket approval, as they are considered to have the highest risk and may be life-sustaining or supporting.

All manufacturers of medical devices have requirements they must follow. For Class II and III devices and some Class I devices, this includes following design controls as laid out in 21 CFR 820.30. The entity submitting the product for 510(k) premarket notification must be able to provide the design control documentation to the FDA during a site inspection.

Changes made to the specifications for a medical device or changes to the manufacturing process may require a new 510(k) submission.

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Medical Devices and Premarket Notification

Devices that are designed to be substantially equivalent to products that are already on the market essentially have a pre-written blueprint for their approval by CDRH. The requirements for notifying the FDA prior to marketing a medical device have been changed over the decades, but they are all designed to protect the health and safety of people.

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