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This document provides a comprehensive summary of the 510(k) premarket notification for the Control Set DAT I, DAT II, DAT III, Control Set Amphetamine 1000, and Control Set Amphetamine 500, detailing

How to fill out 510k summary - accessdata

How to fill out 510(k) Summary

1. Identify the device and its intended use.
2. Determine the classification of the device.
3. Gather information on the predicate device(s) used for comparison.
4. Prepare a description of the device, including design and materials.
5. Submit performance testing results, including bench, animal, or clinical data if applicable.
6. Address safety and efficacy concerns.
7. Complete the 510(k) application form accurately.
8. Include labeling information as per FDA requirements.
9. Review the entire summary for accuracy and completeness.
10. Submit the 510(k) Summary to the FDA for evaluation.

Who needs 510(k) Summary?

1. Manufacturers of medical devices that are classified as Class II or some Class I devices.
2. Companies intending to market a new medical device that is substantially equivalent to a device already on the market.
3. Developers of any device that has undergone significant modifications.

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; it outlines how the device is comparable to a legally marketed device.

Who is required to file 510(k) Summary?

Manufacturers of medical devices intending to market their device in the U.S. must file a 510(k) Summary if the device is not exempt and is classified under the FDA regulations.

How to fill out 510(k) Summary?

To fill out a 510(k) Summary, the manufacturer must provide details about the device, including its intended use, technological characteristics, comparisons to predicate devices, and supporting evidence of safety and effectiveness.

What is the purpose of 510(k) Summary?

The purpose of the 510(k) Summary is to demonstrate to the FDA that the new device is substantially equivalent to an existing legally marketed device, thereby allowing it to be marketed without undergoing the more rigorous premarket approval process.

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

The 510(k) Summary must report device identification information, intended use, a description of the technology, performance testing results, a comparison with predicate devices, and labeling information.