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This document summarizes the 510(k) premarket notification for the ProSound C3 Ultrasound System, detailing the device's name, intended use, technological characteristics, and compliance with safety

How to fill out 510k summary - accessdata

How to fill out 510(k) Summary

1. Identify the device to be submitted.
2. Gather all relevant information and data about the device, including intended use and comparisons to similar devices.
3. Prepare a comprehensive description of the device, including design, materials, and specifications.
4. Compile performance testing results, including any clinical data, if applicable.
5. Fill out the 510(k) submission form accurately, including the contact information and device classification.
6. Complete the 510(k) Summary, summarizing the key information and differences from predicate devices.
7. Review the document for compliance with FDA requirements.
8. Submit the 510(k) Summary along with any necessary fees to the FDA.

Who needs 510(k) Summary?

1. Manufacturers of medical devices that are classified as moderate risk (Class II) and require FDA clearance before marketing.
2. Companies looking to introduce new devices that are substantially equivalent to existing approved devices (predicate devices).
3. Businesses seeking to ensure regulatory compliance for new medical devices with intended uses similar to existing devices.

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, demonstrating that it is safe and effective by showing substantial equivalence to a legally marketed device.

Who is required to file 510(k) Summary?

Manufacturers of medical devices that intend to market a device that is not exempt and is significantly different from a previously approved device must file a 510(k) Summary with the FDA.

How to fill out 510(k) Summary?

To fill out a 510(k) Summary, manufacturers must provide details about the device, its intended use, descriptions, labeling, and information about the significant equivalence to a predicate device, along with appropriate testing data.

What is the purpose of 510(k) Summary?

The purpose of the 510(k) Summary is to inform the FDA and the public about the safety and effectiveness of a medical device, ensuring that it is substantially equivalent to a pre-existing device.

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

The 510(k) Summary must report the device name, manufacturer information, indications for use, device description, substantial equivalence justification, and safety and effectiveness data, among other relevant information.