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This document summarizes the premarket notification for the Diatron Abacus 5, an automated hematology analyzer intended for in-vitro diagnostic use in clinical laboratories, detailing its specifications,

How to fill out 510k summary - accessdata

How to fill out 510(k) Summary

1. Identify the device for which you are submitting the 510(k).
2. Gather all necessary information about the device, including its intended use and technological characteristics.
3. Review the FDA's guidelines for 510(k) submissions to ensure compliance.
4. Conduct a comparison with a legally marketed device (predicate) to demonstrate substantial equivalence.
5. Prepare the 510(k) Summary, including device description, intended use, and comparisons to the predicate device.
6. Include information on the results of any testing that supports your claims.
7. Submit the 510(k) Summary through the FDA's electronic submission gateway.
8. Pay the applicable user fee if required.
9. Monitor the status of the submission and be prepared to respond to any FDA inquiries.

Who needs 510(k) Summary?

1. Manufacturers of medical devices that are intended for commercial distribution in the U.S.
2. Companies seeking to market devices that are substantially equivalent to a predicate device already on the market.
3. Any business that wants to obtain clearance from the FDA to sell their medical 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?

The 510(k) Summary is a document submitted to the FDA that provides information about a medical device and demonstrates that it is safe and effective for its intended use, based on substantial equivalence to a legally marketed device.

Who is required to file 510(k) Summary?

Manufacturers of medical devices that are not exempt from premarket notification and wish to market their device in the United States must file a 510(k) Summary with the FDA.

How to fill out 510(k) Summary?

To fill out a 510(k) Summary, manufacturers must include detailed information such as device description, intended use, technological characteristics, summary of data supporting the claims of substantial equivalence, and any test results or clinical data available.

What is the purpose of 510(k) Summary?

The purpose of the 510(k) Summary is to provide the FDA with sufficient information to determine whether the medical device is substantially equivalent to a device already legally marketed in the U.S., thereby ensuring its safety and effectiveness.

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

The information that must be reported includes the device name, the manufacturer's name, a description of the device, indications for use, comparison to predicate devices, performance data, labeling, and any adverse events associated with the device.