Understanding the Basics of 510(k) Submission Process
Bringing a medical device into the US market involves complex regulatory requirements. The 510(k) process is one of the most common pathways for the manufacturers of medical device. This pathway allows manufacturing companies to display that the new medical device is similar to the predicate device present in the market and is FDA-cleared.
In this guide, we will delve into the details of the 510(k) submission process, including its legal foundation, the types of devices requiring a 510(k) medical device clearance, exemptions, the three types of FDA 510(k) submissions, annual submission statistics, and recent FDA 510(k) approval process updates.
What is a 510(k) Submission?
A 510(k) submission, also called as premarket notification is a submission made by medical device manufacturing companies to the USFDA. The submission is required for newly launched medical device to be safe and effective as that of the existing medical device which is marketed legally.
The name 510(k) comes from the 510(k) section from the FD&C Act. It demands that the medical device companies must inform the FDA 90 days before launching the device if it does not require a premarket approval (PMA). The FDA then evaluates if the new device is equivalent to that of the existing medical device. If approved, the manufacturer receives 510(k) clearance, allowing them to commercially distribute the device in the U.S. market.
Legal Basis for a 510(k) Submission
Section 510(k) of the FD&C Act outlines the requirements of the 510(k) submission which states that the manufacturing companies must submit a premarket notification to the FDA before marketing the device until and unless the device is exempt. The FDA 510(k) process evaluates if the new device is similar to an already marketed device and whether it poses the same level of risk to users.
A device must go through the FDA 510(k) submission if it:
- Has a different technological characteristic from a legally marketed predicate device but does not raise new concerns about safety or effectiveness.
- Falls under the classification of a device that requires 510(k) clearance before being introduced to the market.
- Is intended for human use but does not require premarket approval (PMA).
When is a 510(k) Required?
According to the FDA’s guidelines, a 510(k) submission is required when:
- A manufacturer introduces a new medical device that does not yet have FDA 510(k) clearance.
- A manufacturer significantly modifies an existing device which might affect the safety and effectiveness.
- The device falls under the categories of Class I, II, or III medical devices requiring 510(k) submission as per FDA medical device registration classification.
- The device is not exempt from 510(k) submission requirements under FDA regulations.
When is a 510(k) Not Required?
Certain medical devices do not require a 510(k) submission. According to the FDA:
- Class I devices that are exempt from the 510(k) process, such as manual stethoscopes, elastic bandages, and other low-risk devices, do not require submission.
- Devices that have already been cleared through a premarket approval (PMA) process do not need an additional 510(k) submission.
- Customized medical devices based on patients.
- Devices which are not affected based on any modifications.
A detailed list of the medical devices which are exempted are available at FDA’s website.
Types of 510(k) Submissions
1. Traditional 510(k)
The most commonly used pathway for obtaining FDA clearance for a new device. The manufacturer must demonstrate substantial equivalence to an already marketed device.
2. Special 510(k)
Used when a manufacturer modifies their own previously cleared device, provided the modifications do not affect the intended use or fundamental technology.
3. Abbreviated 510(k)
Utilized when the FDA provides recognized guidance documents, special controls, or voluntary consensus standards to support a streamlined FDA 510(k) submission process.
The FDA eSTAR Program Implementation
This is an electronic submission template that standardizes the 510(k) submission process. It aims at improving factors like efficiency, consistency and completeness in the registration submission of medical devices.
The 510(k) Third-Party Review Program
Authorized third party reviewers are allowed to evaluate 510(k) submissions before final submission to the FDA. This allows accredited third-party reviewers to assess 510(k) submissions before submission to the FDA. It speeds up the FDA approval process and the review time gets reduced.
Annual 510(k) Submission Statistics
Annually, the FDA receives 3000 plus submissions of 510(k) and the clearance rate of these submissions are usually 85%, which indicates the importance of well-prepared submissions.
Recent 510(k)-Cleared Devices
Below is a list of recently cleared devices:
Conclusion
Medical device manufacturers need to navigate the 510(k) submission process with the FDA. Once device firms understand the requirements and exemptions that pertain to medical device startups, along with FDA regulatory compliance, they can put their medical device to market. Qualified 510(k) experts can by working with a qualified FDA 510(k) consultant one can help avoid denial of 510(k) submission and make the approval process more efficient.
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