Get the free 510(k) Summary - accessdata fda

This document serves as a 510(k) premarket notification for the apolloTM system, detailing its intended use, device description, predicate devices, and compliance with medical device regulations.

How to fill out 510k summary - accessdata

How to fill out 510(k) Summary

1. Identify the device and its intended use.
2. Gather supporting data, including safety and effectiveness information.
3. Prepare a description of the device, including its design and materials.
4. Compare the device to a legally marketed predicate device.
5. Provide a summary of the testing conducted, including clinical data if applicable.
6. Include labeling information for the device.
7. Review and organize all documents for clarity and completeness.
8. Submit the 510(k) Summary electronically through the FDA's submission portal.

Who needs 510(k) Summary?

1. Manufacturers of medical devices seeking market approval in the United States.
2. Companies proposing changes to existing devices that require substantial equivalence determination.
3. Organizations wishing to market a new device that is similar to an already marketed device.

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 outlines information about a medical device, demonstrating that it is substantially equivalent to a device that is already legally marketed.

Who is required to file 510(k) Summary?

Manufacturers of medical devices that are intended for commercial distribution in the U.S. must file a 510(k) Summary if their device is not exempt from premarket notification.

How to fill out 510(k) Summary?

To fill out a 510(k) Summary, manufacturers must complete a premarket notification form, providing detailed information about the device's design, intended use, performance data, and any labeling, among other required information.

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 device's safety and effectiveness and to demonstrate its substantial equivalence to an existing, legally marketed device.

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

The 510(k) Summary must report the device name, applicant's information, intended use, technology description, performance testing results, labeling, and comparisons to predicate devices.