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This document provides a summary of the premarket notification for the ILUMAVision software, detailing its intended use, device classification, and substantial equivalence to previously cleared devices.

How to fill out premarket notification 510k summary

How to fill out Premarket Notification (510(k)) Summary

1. Identify the device for which you are submitting the 510(k) notification.
2. Determine if the device is substantially equivalent to a legally marketed device.
3. Collect data and information about the device’s intended use, technological characteristics, and performance.
4. Prepare the Premarket Notification (510(k)) Summary document including device description, intended use, and comparison to predicate devices.
5. Include any required test results and clinical data supporting the claims of equivalence.
6. Complete the Cover Letter, including the submitter’s contact information and a statement of compliance.
7. Submit your 510(k) application electronically to the FDA.

Who needs Premarket Notification (510(k)) Summary?

1. Manufacturers of medical devices who wish to market a device that is not exempt from premarket notification.
2. Companies introducing a device that is similar to an existing, legally marketed device.
3. Anyone seeking to ensure that their device meets the regulatory requirements for safety and effectiveness.

People Also Ask about

What is the rejection rate for 510K?

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 is a 510 K premarket notification?

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.

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.

How long will it take my 510 K to be cleared by the US FDA?

Once the FDA have received your submission, the FDA will officially start the clock on your decision timeline. At the time of writing the FDA states that a traditional 510(k) decision should be provided within 90 days.

What is the difference between 510K and premarket approval?

What's the difference between a 510K vs PMA? 510(k) clearance is authorisation from the FDA to market a medium-risk medical device, while PMA (premarket approval) is required for more high-risk and novel products.

How long does it take for the 510 K determination in the case of traditional premarket notification?

Most class I and class II devices are exempt from 510(k) requirements. Devices that may be 510(k) exempt include: Preamendment devices (devices legally marketed in the US prior to May 28, 1976) Class I devices specifically exempted by FDA or classified as class I under section 513 (with certain exceptions)

For pdfFiller’s FAQs

What is Premarket Notification (510(k)) Summary?

Premarket Notification (510(k)) Summary is a submission made to the FDA to demonstrate that a medical device is safe and effective and substantially equivalent to a legally marketed device.

Who is required to file Premarket Notification (510(k)) Summary?

Manufacturers of medical devices that are not exempt from premarket notification requirements are required to file a Premarket Notification (510(k)).

How to fill out Premarket Notification (510(k)) Summary?

To fill out the Premarket Notification (510(k)) Summary, manufacturers must provide detailed information about the device, including its intended use, technological characteristics, and evidence supporting its safety and effectiveness.

What is the purpose of Premarket Notification (510(k)) Summary?

The purpose of the Premarket Notification (510(k)) Summary is to inform the FDA about a new medical device's safety and effectiveness and to establish its substantial equivalence to an existing, legally marketed device.

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

Information that must be reported includes device description, indications for use, information on substantial equivalence, summary of technological characteristics, performance testing data, and labeling information.