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This document summarizes the 510(k) premarket notification of safety and effectiveness for a disposable non-sterile powder-free vinyl examination glove intended for medical use, highlighting the device's

How to fill out 510k summary - accessdata

How to fill out 510(k) Summary

1. Identify the product for which you are submitting the 510(k) Summary.
2. Determine whether your device is substantially equivalent to a legally marketed device.
3. Gather necessary documentation, including device description, intended use, and indications for use.
4. Compile data from bench tests, clinical studies, and other relevant information to support your submission.
5. Complete the 510(k) form, ensuring all sections are filled out accurately.
6. Prepare a summary of the safety and effectiveness data, making sure it is clear and concise.
7. Submit the 510(k) Summary electronically to the FDA through their submission portal.
8. Pay the required user fee, if applicable, for the 510(k) application.

Who needs 510(k) Summary?

1. Manufacturers and developers of medical devices that need to demonstrate substantial equivalence to a previously cleared device.
2. Companies introducing new medical devices that are not classified as Class III or that can opt for the 510(k) pathway.
3. Organizations looking to market diagnostic devices, surgical instruments, or other types of medical products.

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 demonstrates that a medical device is safe and effective and is substantially equivalent to a device legally marketed in the U.S.

Who is required to file 510(k) Summary?

Manufacturers of medical devices intended for marketing in the U.S. are required to file a 510(k) Summary if they are seeking to demonstrate that their device is substantially equivalent to one or more legally marketed devices.

How to fill out 510(k) Summary?

Filling out a 510(k) Summary requires detailed information about the device, including its name, manufacturer, intended use, technological characteristics, performance data, and a comparison to predicate devices.

What is the purpose of 510(k) Summary?

The purpose of a 510(k) Summary is to provide the FDA with information necessary to determine whether a medical device is safe and effective, allowing it to be marketed in the U.S.

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

The 510(k) Summary must report information such as the device description, intended use, indications for use, comparison to predicate devices, and performance testing results.