Get the free 510(k) Summary - accessdata fda

This document provides a summary of the 510(k) Safety and Effectiveness information for the FreeStyle Freedom Blood Glucose Monitoring System, including its intended use and comparison with predicate

How to fill out 510k summary - accessdata

How to fill out 510(k) Summary

1. Identify the device you are submitting for FDA clearance.
2. Gather relevant data and documentation about the device, including its intended use and technological characteristics.
3. Research and identify a predicate device that has already been cleared by the FDA.
4. Prepare the 510(k) Summary, including the decision-making process, a description of the device, and comparisons with the predicate device.
5. Include information on performance testing, safety, and effectiveness, if applicable.
6. Review the 510(k) Summary for compliance with FDA guidelines before submission.
7. Submit the 510(k) Summary to the FDA along with the required forms and fees.

Who needs 510(k) Summary?

1. Manufacturers of medical devices who wish to market their devices in the United States and determine if their device is substantially equivalent to a legally marketed device must submit a 510(k) Summary.
2. Companies introducing new devices or changes to existing devices that may affect their 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 information about a medical device that is intended to demonstrate that the device is safe and effective and is substantially equivalent to a device already legally marketed.

Who is required to file 510(k) Summary?

Manufacturers of medical devices that intend to market a device that is not significantly different from an existing one must file a 510(k) Summary to the FDA before commercialization.

How to fill out 510(k) Summary?

To fill out a 510(k) Summary, one must provide detailed information about the device, including its intended use, technological characteristics, performance data, labeling, and a comparison to the predicate device.

What is the purpose of 510(k) Summary?

The purpose of the 510(k) Summary is to provide the FDA and the public with information regarding the medical device, ensuring that it meets safety and effectiveness standards before it can be marketed.

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

Information that must be reported includes the device name, manufacturer details, intended use, descriptions of the device, comparison to predicate devices, performance testing results, and proposed labeling.