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This document provides a summary of the safety and effectiveness information for the Iso-Gard HEPA Filter-HME and Iso-Gard HEPA Filter-HME with Port, submitted to demonstrate substantial equivalence

How to fill out 510k summary of safety

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

1. Identify the device classification and predicate device.
2. Gather necessary data about the device, including intended use and technological characteristics.
3. Conduct performance testing and compile the results into a format suitable for submission.
4. Prepare a description of the device’s design and manufacturing process.
5. Include labeling information that accurately represents the device.
6. Write a summary of all safety and effectiveness information, including comparisons to the predicate device.
7. Ensure all applicable standards and regulatory requirements are met.
8. Review the summary for accuracy and completeness before submission.

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

1. Manufacturers of medical devices who wish to market their products in the United States and are required to provide evidence of safety and effectiveness based on a predicate device.

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 by manufacturers of medical devices to demonstrate that their device is as safe and effective as a legally marketed device. It provides information about the device's intended use, technological characteristics, and performance data.

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

Medical device manufacturers who intend to market a device that is not classified as a Class III device are required to file a 510(k) Summary. This includes manufacturers who are introducing a new device or modifying an existing device.

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

To fill out a 510(k) Summary of Safety and Effectiveness, manufacturers must provide information including device name, intended use, physical description, technological characteristics, performance testing results, labeling, and any substantial equivalence claims to a predicate device.

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 provide the FDA with sufficient evidence to determine that a new or modified device is safe and effective for its intended use, ensuring that it can be legally marketed in the United States.

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

The information that must be reported includes the device's name, the manufacturer's details, intended use and indications for use, a description of the device, comparisons to predicate devices, summaries of non-clinical and clinical data, and proposed labeling. Additionally, any relevant performance testing data should be included.