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This document provides a summary of the 510(k) submission for the Embletta MPR Sleep Data Recording System, detailing device identification, specifications, intended use, predicates, testing, and

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 technical specifications and intended use.
3. Conduct a comparison with a legally marketed predicate device to demonstrate substantial equivalence.
4. Prepare a comprehensive summary of the device, including descriptions, intended use, and mode of operation.
5. Include labeling, advertising materials, and indications for use.
6. Compile safety and effectiveness data, including any clinical studies if applicable.
7. Complete the 510(k) form and ensure all sections are accurate and complete.
8. Submit the 510(k) summary electronically through the FDA’s submission portal.
9. Respond promptly to any inquiries or additional information requests from the FDA.

Who needs 510(k) Summary?

1. Manufacturers of medical devices that are to be marketed in the United States.
2. Companies seeking FDA clearance for devices that are similar to existing products.
3. Organizations intending to modify/design new medical devices that affect safety or effectiveness.
4. Importers of devices that require FDA review before being sold in the U.S.

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 and is substantially equivalent to a legally marketed device.

Who is required to file 510(k) Summary?

Manufacturers of certain medical devices that are not exempt from premarket notification are required to file a 510(k) Summary before the device can be marketed in the United States.

How to fill out 510(k) Summary?

To fill out a 510(k) Summary, manufacturers must gather relevant information about their device, including device description, intended use, technological characteristics, and comparisons to predicate devices. They then complete the FDA's specified form and provide supporting documentation.

What is the purpose of 510(k) Summary?

The purpose of the 510(k) Summary is to provide the FDA with information necessary to determine whether the new device is safe and effective and if it can be classified as substantially equivalent to an existing device.

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

The information required in a 510(k) Summary includes device name, applicant information, device description, intended use, technological characteristics, and performance data including any known risks or benefits.