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This document summarizes the safety and effectiveness of the TRUFILL DCS ORBIT Detachable Coil and Syringe, intended for embolizing intracranial aneurysms and vascular malformations.

How to fill out 510k summary of safety

How to fill out 510(k) Summary of Safety and Effectiveness

1. Identify the device and its intended use.
2. Gather relevant data and information related to the device's safety and effectiveness.
3. Compile a summary of the device's technological characteristics, including differences from predicate devices.
4. Include clinical data, if applicable, to support safety and effectiveness claims.
5. Prepare a discussion of the device's potential risks and benefits.
6. Ensure the summary is clear, concise, and formatted according to FDA guidelines.
7. Review and revise the document for accuracy and completeness.
8. Submit the 510(k) summary electronically through the FDA's submission system.

Who needs 510(k) Summary of Safety and Effectiveness?

1. Manufacturers of medical devices that are intended for commercial distribution in the United States.
2. Companies introducing new medical devices that are similar to existing devices (predicate devices).
3. Firms seeking FDA clearance to market their devices based on safety and effectiveness.

People Also Ask about

What is the 501k process?

The 510(k) regulatory pathway is a submission process that medical device manufacturers use to get clearance from the FDA to market an eligible product in the U.S. Under the 510(k) pathway, a medical device manufacturer submits a premarket notification to the FDA, which includes information about the device's intended

What is the rejection rate for 510k?

The FDA 510(k) Program is occasionally referred to as premarket notification. It allows a new medical device to gain FDA approval by establishing a set of similarities to a current medical device that is already on the market.

What is the content of 510k summary?

The 510(k) Statement is a certification that the 510(k) owner will provide safety and effectiveness information supporting the FDA finding of substantial equivalence to ANY person within 30 days of a written request.

How long does FDA 510 K approval take?

The FDA 510(k) submission process is a critical gateway for medical device manufacturers seeking approval for their products in the United States. However, a concerning trend has emerged – a staggering 25% of these submissions are facing rejection due to lack of completeness.

What are the three types of 510k?

There are three types of Premarket Notification 510(k)s that may be submitted to the FDA: Traditional, Special, and Abbreviated. In 1998, the FDA developed both the Special and Abbreviated 510(k) Programs to facilitate the review of certain types of submissions subject to 510(k) requirements.

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.

Is 510k safe and effective?

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act).

For pdfFiller’s FAQs

What is 510(k) Summary of Safety and Effectiveness?

The 510(k) Summary of Safety and Effectiveness is a document submitted to the FDA that provides information about a medical device, demonstrating that it is safe and effective for its intended use and is substantially equivalent to a legally marketed device.

Who is required to file 510(k) Summary of Safety and Effectiveness?

Any manufacturer or entity that intends to market a medical device in the United States which is not exempt from premarket notification requirements must file a 510(k) Summary of Safety and Effectiveness.

How to fill out 510(k) Summary of Safety and Effectiveness?

To fill out the 510(k) Summary of Safety and Effectiveness, manufacturers must provide detailed information about the device, including its description, intended use, labeling, and data supporting its safety and effectiveness, as per FDA guidelines.

What is the purpose of 510(k) Summary of Safety and Effectiveness?

The purpose of the 510(k) Summary of Safety and Effectiveness is to ensure that new medical devices are as safe and effective as existing devices before they can be marketed, thus protecting public health.

What information must be reported on 510(k) Summary of Safety and Effectiveness?

The 510(k) Summary must include device name, manufacturer information, intended use, technological characteristics, performance testing results, and any labeling information, among other required data.