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This document provides a summary of safety and effectiveness for the APLIO ARTIDA Diagnostic Ultrasound System, detailing its regulatory classification, intended use, and comparison with predicate

How to fill out 510k summary of safety

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

1. Start with a title section that includes the device name and number.
2. Provide the submitter's details, including name and address.
3. Summarize the purpose of the device and its intended use.
4. Describe the device's design, materials, and specifications.
5. Include performance data, clinical studies, and safety data.
6. Compare the device with a predicate device to demonstrate substantial equivalence.
7. Compile any labeling information, including warnings and instructions for use.
8. Sign and date the summary, ensuring all required information is complete.

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

1. Manufacturers of medical devices that are seeking to market new devices that are substantially equivalent to an already legally marketed device.
2. Developers of medical devices that fall into categories requiring FDA clearance before commercialization.
3. Companies looking to demonstrate safety and effectiveness of their device to the FDA.

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 to demonstrate that a medical device is safe and effective by showing substantial equivalence to a legally marketed device.

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

Manufacturers of medical devices that are seeking market clearance under the FDA's 510(k) program are required to file this summary when their device is not exempt from premarket notification requirements.

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

To fill out the 510(k) Summary, manufacturers must include information about the device's name, intended use, description, substantial equivalence claim, and data supporting safety and effectiveness, along with any applicable test results.

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

The purpose of the 510(k) Summary is to provide the FDA with information that demonstrates that the new device is as safe and effective as an already marketed device, thereby facilitating timely access to new medical technologies.

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

The 510(k) Summary must include the device name, intended use, summary of technological characteristics, comparison to predicate devices, performance testing data, labeling information, and any additional safety and effectiveness information.