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This document provides a summary of the premarket notification for the VitaScan LT, including device details, intended use, technological characteristics, and performance data, in compliance with

How to fill out 510k summary - accessdata

How to fill out 510(K) Summary

1. Identify the device: Clearly define the medical device you are submitting for clearance.
2. Choose the predicate device: Find a legally marketed device that is similar to your device for comparison.
3. Provide a description: Include a detailed description of your device, its intended use, and any components.
4. Summarize technological characteristics: Detail the technological aspects of your device as compared to the predicate.
5. Cite safety and effectiveness: Provide evidence that your device is safe and effective for its intended use.
6. Include labeling: Submit proposed labeling that aligns with the device’s use and user instructions.
7. Compile summary of testing: Include results from any necessary bench, animal, or clinical testing.
8. Prepare the summary: Create a clear and concise summary of all the information, organized appropriately.
9. Review and submit: Double-check the summary for completeness and accuracy before submission.

Who needs 510(K) Summary?

1. Manufacturers of medical devices who wish to market their device in the U.S.
2. Companies seeking FDA clearance for devices that are similar to previously marketed products.
3. Businesses looking to demonstrate that their new device is safe and effective based on substantial equivalence.

People Also Ask about

What is the content of a special 510k?

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 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

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 is the 510 K process?

Most 510(k)s will include some type of performance data. The extent of performance data will depend on the complexity of the device and its intended use and indications. Performance data should be provided to help demonstrate SE of your device to one or more legally marketed devices (predicate device).

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.

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.

For pdfFiller’s FAQs

What is 510(K) Summary?

The 510(k) Summary is a document submitted to the FDA that outlines information about a medical device's safety and effectiveness based on comparison to a legally marketed device.

Who is required to file 510(K) Summary?

Manufacturers intending to market a medical device that is not substantially equivalent to an existing device must file a 510(k) Summary with the FDA.

How to fill out 510(K) Summary?

To fill out the 510(k) Summary, manufacturers must provide details on device description, intended use, comparisons to predicate devices, safety and effectiveness data, labeling, and any other relevant information.

What is the purpose of 510(K) Summary?

The purpose of the 510(k) Summary is to demonstrate to the FDA that the new device is safe and effective for its intended use and is substantially equivalent to a predicate device.

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

The 510(k) Summary must include device specifications, intended use, labeling, substantial equivalence comparisons, and performance testing results, among other pertinent information.