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This document provides a detailed summary of the 510(k) premarket notification for the Motiva Monitor Device Connectivity, including device specifications, intended use, technological characteristics,

How to fill out 510k summary - accessdata

How to fill out 510(k) Summary

1. Determine if your device requires a 510(k) submission by assessing its classification.
2. Gather device information, including intended use, indications for use, and technical specifications.
3. Identify the predicate device to which you are comparing your device.
4. Conduct performance testing and risk analysis to demonstrate safety and effectiveness.
5. Prepare a comprehensive summary that includes device description, predicate comparison, and study data.
6. Include labeling information and any other relevant documentation as required by FDA guidelines.
7. Review and revise the summary to ensure accuracy and compliance.
8. Submit the 510(k) Summary to the FDA along with the required filing fee.

Who needs 510(k) Summary?

1. Manufacturers of medical devices that are Class I (exempt), Class II, or certain Class III devices.
2. Companies looking to market a new device that is substantially equivalent to an existing legally marketed device.
3. Organizations seeking to gain FDA clearance to sell their devices in the United States.

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 to demonstrate that a medical device is safe and effective for its intended use, being substantially equivalent to already marketed devices.

Who is required to file 510(k) Summary?

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

How to fill out 510(k) Summary?

To fill out a 510(k) Summary, manufacturers must provide device descriptions, intended use, a comparison to a predicate device, substantial equivalence claims, and any required performance data.

What is the purpose of 510(k) Summary?

The purpose of a 510(k) Summary is to inform both the FDA and the public about the device's characteristics and how it is equivalent to existing devices, ensuring safety and effectiveness.

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

The 510(k) Summary must report device identification, intended use, technological characteristics, comparison to predicate devices, performance testing results, and labeling information.