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How to fill out 510k summary - accessdata

How to fill out 510(k) Summary

1. Identify the device classification: Determine whether your device is classified as Class I, II, or III.
2. Gather device information: Compile detailed information about your device, including its intended use, design, materials, and technological characteristics.
3. Prepare a comparison: Identify a legally marketed device (predicate device) that is similar to your device and document the comparison.
4. Conduct performance testing: Collect data from performance, safety, and efficacy tests to demonstrate substantial equivalence to the predicate device.
5. Fill out the 510(k) form: Use the FDA's 510(k) submission form to provide all required information about your device and support your claims.
6. Compile the summary: Write a summary that includes the device description, intended use, technology comparisons, and any relevant test results.
7. Review and finalize: Ensure all information is complete and accurate before submission.
8. Submit the 510(k): Send the completed 510(k) submission to the FDA for evaluation.

Who needs 510(k) Summary?

1. Manufacturers of medical devices seeking to market their products in the United States.
2. Companies producing devices that are not exempt from premarket notification requirements.
3. Any entity that plans to introduce a device that is substantially equivalent to an already marketed device.

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?

A 510(k) Summary is a document submitted to the FDA that provides a summary of safety and effectiveness data for a medical device that is being marketed in the United States. It is part of the premarket notification process for devices indicated as substantially equivalent to a legally marketed device.

Who is required to file 510(k) Summary?

Manufacturers of medical devices that are planning to market a device in the U.S. that is not exempt from premarket notification requirements are required to file a 510(k) Summary with the FDA.

How to fill out 510(k) Summary?

To fill out a 510(k) Summary, manufacturers must provide detailed information about the device, including its intended use, technological characteristics, performance data, and comparison to a predicate device. The form must be completed according to FDA guidelines.

What is the purpose of 510(k) Summary?

The purpose of the 510(k) Summary is to demonstrate that a new medical device is safe and effective for its intended use, and to confirm that it is substantially equivalent to a legally marketed device.

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

The information that must be reported on a 510(k) Summary includes the device name, type, intended use, description of the device, summary of technological characteristics, requirements for safety and effectiveness, and performance testing data.