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This document provides a summary and details regarding the 510(k) submission for the FreeStyle InsuLinx Blood Glucose Monitoring System, including regulatory information, device features, intended

How to fill out 510k summary - accessdata

How to fill out 510(k) Summary

1. Determine if your device requires a 510(k) submission.
2. Collect all relevant information about your device, including its design, labeling, and intended use.
3. Identify the predicate device (an already legally marketed device) that is most similar to your device.
4. Perform a safety and effectiveness assessment comparing your device to the predicate device.
5. Prepare the 510(k) summary, including a description of the device, indications for use, technological characteristics, and a summary of the performance testing.
6. Submit the 510(k) summary to the FDA for review.

Who needs 510(k) Summary?

1. Manufacturers of medical devices intending to market a device in the U.S.
2. Companies introducing a new device that is significantly different from existing devices on the market.
3. Businesses seeking to establish equivalence with a predicated device for regulatory approval.

People Also Ask about

What are the three types of 510k?

There are three types of 510(k) submissions: Traditional, Abbreviated, and Special. Each type has its own requirements and may be appropriate for different types of medical devices. Traditional, Special, and Abbreviated 510(k)s require the same user fee.

What is the difference between 510k de novo and PMA?

PMA submissions are intended for high-risk devices, whereas De Novo and 510(k) are suitable for lower-risk devices with suitable predicates. Choosing the right submission pathway depends on various factors, including your device's risk level, the availability of predicates, and the resources you have available.

What are the different types of 510k s?

Types of 510(k)s. If your medical device is eligible under premarket notification criteria, there are three types of 510(k)s: Traditional, Abbreviated, and Special. The FDA offers separate checklists for the Traditional, Abbreviated, and Special 510(k)s in its Refuse to Accept Policy for 510(k)s guidance document.

What are class 1, class 2, and class 3 devices?

Class I (low to moderate risk): general controls. Class II (moderate to high risk): general controls and Special Controls. Class III (high risk): general controls and Premarket Approval (PMA)

What is the 510k pathway?

Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k).

What is the purpose of a 510 K to determine?

The focus of the 510(k) process is to prove something called 'substantial equivalence'. In other words, the aim of the game is to prove to the FDA that the medical device you want to bring to market is broadly similar to another device that's already on the market, known as a predicate device.

How long does 501k approval take?

Generally, 510(k) applicants can expect submission acceptance review decisions within 15 calendar days; substantive review decisions within 60 days; and final decisions within 90 days. Applicants with outstanding review issues will be notified within 100 days.

What is the difference between 510k cleared and approved?

When a medical device is cleared, this means it has undergone a 510(k) submission, which FDA has reviewed and provided clearance. Approval: For Class III medical devices to be legally marketed they must undergo a rigorous review and approval process.

For pdfFiller’s FAQs

What is 510(k) Summary?

The 510(k) Summary is a document submitted to the FDA to demonstrate that a medical device is safe and effective by providing evidence that it is substantially equivalent to a predicate device.

Who is required to file 510(k) Summary?

Manufacturers of medical devices that are intended for commercial distribution in the U.S. must file a 510(k) Summary if their device is not exempt and is considered to be substantially equivalent to an already marketed device.

How to fill out 510(k) Summary?

To fill out a 510(k) Summary, manufacturers should gather information about their device, identify a predicate device, describe how their device is similar to the predicate, provide performance data, and include any necessary labeling information.

What is the purpose of 510(k) Summary?

The purpose of the 510(k) Summary is to provide the FDA with information to evaluate the safety and effectiveness of a new medical device and to determine its substantial equivalence to an existing device.

What information must be reported on 510(k) Summary?

The 510(k) Summary must report device name, intended use, description, comparison to predicate device, labeling, performance testing results, and any clinical data if applicable.