Get the free 510(k) Summary - accessdata fda

Este documento presenta un resumen del 510(k) para el dispositivo de fototerapia neonatal BILl-THERAPY Spot, incluyendo su equivalencia sustancial con dispositivos predicados y detalles sobre su uso,

How to fill out 510k summary - accessdata

How to fill out 510(k) Summary

1. Identify the device you are submitting for approval.
2. Gather relevant data that demonstrates the device's safety and effectiveness.
3. Prepare a detailed description of the device, including intended use, technology, and materials.
4. Conduct necessary testing and obtain results to support your claims.
5. Compare your device to a legally marketed device (predicate) in terms of indications for use, design, and performance.
6. Compile all data, including performance testing, labeling, and instructions for use, into a cohesive summary.
7. Fill out the 510(k) submission form and include the summary.
8. Submit the 510(k) Summary to the FDA along with the required fees.
9. Respond to any questions or requests for additional information from the FDA after submission.

Who needs 510(k) Summary?

1. Manufacturers of medical devices that are substantially equivalent to existing products on the market.
2. Companies looking to introduce a new device that does not fall under the exempt categories.
3. Entities seeking approval for changes to already marketed devices that may affect safety or effectiveness.

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 the safety and effectiveness of a medical device that is being marketed in the United States.

Who is required to file 510(k) Summary?

Manufacturers of medical devices that are new or modified and intend to market them in the U.S. are required to file a 510(k) Summary to demonstrate that their product is substantially equivalent to an existing, legally marketed device.

How to fill out 510(k) Summary?

To fill out a 510(k) Summary, manufacturers need to compile information including device description, intended use, comparison to predicate devices, performance testing results, labeling, and any additional relevant data required by the FDA.

What is the purpose of 510(k) Summary?

The purpose of the 510(k) Summary is to provide the FDA with information that allows them to determine whether a device is safe and effective and can be marketed based on its substantial equivalence to a predicate device.

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

The 510(k) Summary must report information such as the device name, intended use, technological characteristics, summary of non-clinical and clinical testing, and any other data demonstrating substantial equivalence.