510(K) Premarket Notification – US Food & Drug Administration

IBC assists organizations in achieving 510K premarket notification with the US FDA. A premarket notification, also known as a “premarket submission” or “510(k)”, is a process used by medical device manufacturers to demonstrate to the FDA that their device is substantially equivalent to a legally marketed device already on the market (known as the “predicate” or “reference” device). This allows for a faster clearance process as it requires less evidence from clinical trials. The 510(k) premarket notification process was established to accelerate the introduction of new devices that are considered substantially equivalent to devices already legally marketed for the same use.

The Basics: What is a 510(k)?

The 510(k) premarket notification process is utilized by medical device manufacturers to legally market a new medical device. Manufacturers must submit technical information through a Premarket Notification [510(k)] Application to the FDA, which is then evaluated for safety, effectiveness, and labeling by FDA scientists.

Examples of devices that may undergo 510(k) clearance include those used in general wellness, diagnostic imaging equipment, blood sample collection and processing, surgical devices, and devices for diagnosing and treating illnesses or injuries.

For some devices, more stringent regulations require compliance before marketing. Manufacturers may need an Investigational Device Exemption (IDE) for clinical trials on humans or submit a Premarket Approval (PMA) for devices already used on humans.

Medical device manufacturers often have questions about bringing Class II or high-risk Class III devices to the U.S., especially when using international sales subsidiaries or importing devices. They seek guidance on obtaining FDA approval and legally marketing their devices in the United States, particularly for foreign-made devices reaching U.S. patients.

Design History File (DHF)

The first crucial step in obtaining 510(k) clearance is to organize premarket evidence, which involves creating a Design History File (DHF). IBC provides assistance in preparing a comprehensive DHF, containing essential information about the device’s development and marketing, including documents from clinical trials, research studies, original designs, and any subsequent modifications made since the device’s introduction.

Having a complete and well-structured DHF ensures that your company meets the legal requirements for a 510(k) submission. It is advisable to have the DHF reviewed by professionals familiar with FDA regulations to address all pertinent aspects concerning the device’s safety, effectiveness, labeling, manufacturing processes, and controls.

As a specialized service provider, IBC focuses on helping medical device companies, especially those producing high-risk Class III medical devices, obtain 510(k) clearance. If you require guidance or assistance with the 510(k) premarket notification process, feel free to reach out to us today!

FDA’s Role in the 510(k) Process

The FDA’s Center for Devices and Radiological Health (CDRH) evaluates 510(k) submissions to determine whether a new medical device is substantially equivalent to a legally marketed device or represents a significant advancement in the state of the art for that device type. However, the FDA will not evaluate or draw scientific conclusions about data from another company’s Investigational Device Exemption (IDE) or Premarket Approval (PMA) application. IDE and PMA applications undergo separate scientific review after clinical trial results have been assessed and deemed scientifically sound.

To obtain 510(k) clearance, the submission must provide evidence demonstrating that the device is safe and effective for its intended use, similar to a legally marketed comparable device, or does not introduce any additional risk of illness or injury compared to an existing device on the market. Devices with previous clearance have a higher likelihood of obtaining 510(k) clearance.

Failure to provide sufficient scientific information or unclear data from an IDE or PMA application may lead to FDA refusal of clearance, prompting a request for additional information to address specific aspects of the device’s safety and effectiveness.

FDA’s 510(k) Clearance Process

The 510(k) clearance process involves three steps:

1. Substantial Equivalence Determination: The FDA determines if the device is substantially equivalent to a legally marketed device. If no such devices exist, the FDA assesses if the device is high-risk or substantially equivalent to an investigational device.
2. Safety and Effectiveness Assessment: If the device does not meet the criteria for the above categories or if it’s unclear, the FDA evaluates clinical trial data and scientific evidence to assess the proposed device’s safety and effectiveness.
3. Labeling Review: The FDA reviews the device’s labeling, including indications for use, contraindications, warnings, precautions, adverse reactions, risks, benefits, dosage, and administration. Methods to ensure labeling requirements are met are also evaluated.

The FDA’s determination of substantial equivalence is specific to certain uses, and the device’s labeling must include all identified risks associated with those uses.

Additionally, a 510(k) requires an annual report on any changes made to the product since its initial clearance. Manufacturers must report such changes 30 days before implementing any modifications that could impact the device’s safety or effectiveness.

FDA’s 510(k)Fees for 510k Clearance Process

The FDA’s Center for Devices and Radiological Health (CDRH) has a fee schedule to cover the costs of reviewing, referencing, and cataloging information on marketed devices. Manufacturers are required to pay a fee for the review of the information submitted with their 510(k) application before the review process begins.

Given the complexity of the 510(k) premarket notification process, it is advisable to understand the process beforehand and start the application when ready, rather than waiting until the device needs to be on the market.

The FDA maintains databases containing information on marketed devices, including cleared 510(k) medical device submissions. These databases are updated regularly, and any changes to the device must be reported promptly to the FDA.

Different Types of Submissions

The FDA classifies 510(k) submissions into two categories: Class I and Class II. Class I devices are considered low-risk and do not require a review before they can be marketed. On the other hand, Class II devices have moderate to higher risks compared to Class I devices, and companies must provide scientific data demonstrating that their device is substantially equivalent to another legally marketed device before the FDA will approve it.

The 510(k) submission is a crucial document for a medical device company as it confirms to the FDA that the product complies with public health and safety regulations, allowing the company to market it as an FDA-cleared device.

In the 510(k) submission, detailed information on both the device being submitted for clearance and the predicate device must be provided to establish substantial equivalence between the two.

What Data is Required for Submission?

A 510(k) submission should be comprehensive, providing evidence of the device’s performance and potential risks associated with its use. It should include:

• Intended Use and Description: Clearly define the device’s intended use, performance characteristics, and functions of its components.
• Design Safety: Explain how the product’s design ensures safe and effective use, highlighting any features that prevent misuse or potential hazards.
• Evaluation of Performance: Include test results from bench and/or animal studies, demonstrating the device’s performance and effectiveness.
• Labeling: Describe the device’s labeling, including instructions for use, warnings, and potential risks associated with improper usage.
• Components and Materials: Provide specifications for each component or assembly used in the device, along with information on the materials employed.
• Compliance with Regulations: Present additional information to demonstrate compliance with relevant FDA regulations.

A well-prepared 510(k) submission helps facilitate the review process by providing sufficient data and supporting documentation to establish substantial equivalence with the predicate device.

When a 510(k) is Submitted to the Agency

There are two types of 510(k)s – Class II and Class III.

Class II 510(k): This type of 510(k) notification is submitted when you want to market a product that shares some, but not all, of the characteristics of a legally marketed device that has already been cleared by the FDA or is exempt from review. For instance, it could be a new variation on an existing model or one made with different materials. Class II devices are generally considered to have a lower risk than Class III devices but still have the potential to cause harm.

Class III 510(k): A Class III 510(k) is submitted when you intend to market a product that has a similar intended use and technological characteristics as legally marketed predicate device(s), but there are significant changes in the design, material, chemical composition, energy source, or manufacturing process that could significantly affect the safety or effectiveness of the device. Class III devices are generally higher-risk devices compared to Class II devices.

Validity Period

Validity Period: There is no specified validity period for a 510(k). If you already have an existing 510(k) on file with the FDA and want to add new devices to that submission, you can use the original document as long as you still have all the required information on file.

New Product Submission: If you are submitting a 510(k) for a new product that doesn’t have any similar devices already in the FDA database, your submission must include all the necessary data to demonstrate substantial equivalence at the time of submission. This includes detailed information on intended use, performance characteristics, labeling, test results, components, materials, and compliance with FDA regulations.

Review Process: When you submit a 510(k) to the FDA, the Center for Devices and Radiological Health (CDRH) will review it within 90 days of submission to determine if it’s complete. If any deficiencies or inaccuracies are found, CDRH will contact you to request additional information. If the FDA finds that the new device is not substantially equivalent to a predicate device, they may issue a “Not substantially equivalent” (NSE) letter.

It’s crucial to ensure that your 510(k) submission contains all the necessary information and is accurate to increase the likelihood of a successful clearance by the FDA.

A 510(k) is not required for all medical devices

You don’t need to file a 510(k) for low-risk Class I medical devices, because they’re exempt from review by the FDA. However, to sell Class I devices in interstate commerce, they must be registered with the FDA.

A 510(k) is not required for all modifications

Minor Changes: If you make minor changes to a Class III device that has already been cleared by the FDA, such as producing replacement parts for an FDA-cleared implantable device with no additional safety or effectiveness features, and the new part performs the same function as the original product, you generally do not need to submit a new 510(k).

New 510(k) Submission: However, if you make any changes to the product’s design, materials, or chemical composition that could potentially affect its safety or effectiveness, even if it’s just a part number change, it will be considered a new 510(k) submission.

Change in Intended Use: If your modification alters the intended use of the device from what was already cleared by the FDA, you will have to submit a new 510(k) and potentially conduct clinical trials to demonstrate the safety and effectiveness of the modified device.

When you already have an approved 510(k)

If your FDA-approved device has undergone a 510(k) clearance and you make minor modifications that do not affect safety or effectiveness, a new submission may not be necessary. However, significant changes that could impact safety and effectiveness will require a new 510(k) submission. Each modification should be carefully evaluated to determine the need for additional review.

If you’re planning to sell your device in Europe, Japan or Canada

Minor modifications to an FDA-cleared Class III device should prompt a new 510(k) submission if safety or effectiveness is affected. Other countries may have their own review processes requiring similar information as the US 510(k) for modifications, such as those in the EU, Japan, and Canada.

Medical devices not cleared by the FDA may face additional regulations in other countries. For instance, a Class I orthotic with some added safety features would require review and approval in each country where it will be sold.

The US and EU have mutual recognition agreements for medical devices, recognizing each other’s 510(k) submissions. However, devices not substantially equivalent to existing EU products must apply for CE Marking, unless they can prove substantial equivalence through a 510(k) submission.