Glossary Term
Pre-Market Notification Submission Process
Definition
The pre-market notification submission process, also known as the 510(k) process, is a regulatory procedure used by the U.S. Food and Drug Administration (FDA) for medical devices that are considered low to moderate risk (Class I and Class II devices). Manufacturers must submit a pre-market notification to the FDA to demonstrate that their device is "substantially equivalent" to a device already legally marketed in the U.S. (a predicate device). The 510(k) submission includes data and documentation to show that the new device is as safe and effective as the predicate device and meets the required regulatory standards. This process is typically faster and less costly than the more rigorous Pre-Market Approval (PMA) process for high-risk devices.
Relevance to the MedTech Industry
The purpose of the pre-market notification submission process is to provide a streamlined pathway for the approval of low- and moderate-risk devices, allowing manufacturers to introduce new devices to the market while ensuring that they are safe and effective. By demonstrating substantial equivalence to a predicate device, the process facilitates quicker market access while maintaining regulatory oversight.
Additional Information & Related Terms
What Goes into the Pre-Market Notification Submission Process?
Predicate Device Selection:
A key component of the 510(k) process is selecting a predicate device that is legally marketed and substantially equivalent to the new device. The FDA requires a side-by-side comparison of the new device and the predicate in terms of intended use, design, and performance.
Example: A company developing a new insulin pump may select an existing insulin pump with similar features as the predicate device.
Device Description and Labeling:
The submission must include a detailed description of the device, including its materials, intended use, function, and design. The labeling, including instructions for use, warnings, and contraindications, must also be included to ensure the device is used safely and effectively.
Example: A manufacturer of a new blood pressure cuff submits labeling with instructions on how to use the cuff, along with warnings about proper cuff placement.
Performance Testing:
Manufacturers must provide evidence that their device performs as intended, often through bench testing or laboratory studies. This helps to demonstrate that the new device meets safety and effectiveness requirements and is comparable to the predicate device.
Example: A manufacturer of a new thermometer might submit performance data comparing the accuracy and response time of their device with an already cleared device.
Substantial Equivalence (SE) Claim:
The manufacturer must demonstrate that the new device is substantially equivalent to the predicate device in terms of safety and effectiveness. This includes comparing the two devices’ technological characteristics and performance.
Example: A new glucose monitor may be shown to be substantially equivalent to an existing monitor based on similar technology, accuracy, and intended use.
510(k) Summary or Statement:
The manufacturer must include either a summary of the 510(k) submission or a 510(k) statement that outlines the device’s compliance with FDA regulations. This includes information about any clinical trials or testing conducted, as well as a list of any standards the device meets.
Example: The manufacturer of a new surgical tool submits a 510(k) summary stating that the device meets the required FDA safety standards.
Related Terms
510(k) Clearance: The FDA process for pre-market notification for medical devices that are substantially equivalent to an existing, legally marketed device.
Substantial Equivalence: The determination that a new device is as safe and effective as an existing, legally marketed device (predicate device).
Pre-Market Approval (PMA): A more rigorous FDA approval process for high-risk Class III medical devices that require clinical trials to demonstrate safety and effectiveness.
Class I, II, III Devices: Classification system used by the FDA to categorize medical devices based on risk, with Class I being low-risk and Class III being high-risk.
Risk Management: The process of identifying, assessing, and mitigating risks associated with medical devices, including in the context of pre-market and post-market regulation.