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This document provides a summary of a 510(k) premarket notification for the OsteoSymbionics ST Temporalis Implant, detailing its intended use, device description, indications, and compliance with

How to fill out 510k summary - accessdata

How to fill out 510(k) Summary

1. Identify the device to be submitted and ensure it is a Class II device requiring a 510(k).
2. Gather all necessary information including device description, intended use, and performance characteristics.
3. Conduct comparisons with a legally marketed device (predicate device) and identify similarities and differences.
4. Prepare a labeling section that includes usage instructions, warnings, and indications.
5. Include information on manufacturing processes and quality control measures.
6. Provide clinical data if applicable, or justify the absence of clinical data.
7. Compile the information into a concise summary format that adheres to FDA guidelines.
8. Review and if necessary, revise the summary before submission to ensure completeness and accuracy.
9. Submit the 510(k) Summary to the FDA along with any required fees and supporting documentation.

Who needs 510(k) Summary?

1. Manufacturers of medical devices that are classified as Class II and require market clearance.
2. Companies seeking to market a new device that is similar to an existing, legally 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 provides details about a medical device, including its intended use, technological characteristics, and the basis for demonstrating substantial equivalence to a legally marketed device.

Who is required to file 510(k) Summary?

Manufacturers of certain medical devices that are intended for commercial distribution in the U.S. are required to file a 510(k) Summary if their device is not exempt and is not classified as a low-risk device.

How to fill out 510(k) Summary?

To fill out a 510(k) Summary, manufacturers must complete a series of FDA forms detailing device information, performance testing, labeling, and the substantial equivalence claim. It's essential to follow FDA guidelines for completeness and accuracy.

What is the purpose of 510(k) Summary?

The purpose of the 510(k) Summary is to demonstrate that a new medical device is as safe and effective as an existing legally marketed device, ensuring public health and safety.

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

Information reported on a 510(k) Summary must include device name, intended use, description of the device, the substantial equivalence justification, any safety and effectiveness data, labeling, and a summary of technological characteristics.