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This document summarizes the safety and effectiveness information for the On Call Vivid Blood Glucose Monitoring System submitted under the FDA's 510(k) premarket notification process.

How to fill out 510k summary - accessdata

How to fill out 510(k) SUMMARY

1. Identify the device: Clearly define the medical device and its intended use.
2. Gather information: Collect all necessary data, including device specifications and performance data.
3. Prepare the summary: Write a comprehensive summary that outlines the device's intended use, technological characteristics, and comparisons to a predicate device.
4. Include safety and effectiveness data: Summarize clinical and non-clinical data that demonstrates the device's safety and effectiveness.
5. Provide labeling information: Ensure the summary includes any proposed labeling or instructions for use.
6. Compile references: List all references and supporting documents used in the preparation of the summary.
7. Review and finalize: Carefully review the summary for accuracy and completeness before submission.

Who needs 510(k) SUMMARY?

1. Manufacturers of medical devices that intend to market their products in the U.S. must submit a 510(k) SUMMARY for devices that are not significantly different from a legally marketed predicate device.
2. Companies seeking FDA clearance for new devices or changes to existing devices that require a 510(k) submission.

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 the 510k decision making 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 510k pathway?

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 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.

How long does it take to get a 510 K approval?

It is worth noting that the most common time window to clearance (median) is 80-90 days, followed very closely by 50-60 days.

What is the purpose of a 510 K to determine?

The focus of the 510(k) process is to prove something called 'substantial equivalence'. In other words, the aim of the game is to prove to the FDA that the medical device you want to bring to market is broadly similar to another device that's already on the market, known as a predicate device.

For pdfFiller’s FAQs

What is 510(k) SUMMARY?

The 510(k) SUMMARY is a document submitted to the FDA that provides information about a medical device, including its intended use, technological characteristics, and clinical data, to demonstrate that it is substantially equivalent to a legally marketed device.

Who is required to file 510(k) SUMMARY?

Manufacturers of medical devices that wish to market their products in the United States and claim substantial equivalence to an existing device are required to file a 510(k) SUMMARY.

How to fill out 510(k) SUMMARY?

To fill out a 510(k) SUMMARY, manufacturers must provide detailed information including the device's name, description, labeling, proposed indications for use, substantial equivalence claims, and any clinical and non-clinical data supporting the safety and effectiveness of the device.

What is the purpose of 510(k) SUMMARY?

The purpose of the 510(k) SUMMARY is to provide the FDA with sufficient information to review and determine whether a new medical device is safe and effective, and to ensure that it is comparable to devices that are already on the market.

What information must be reported on 510(k) SUMMARY?

Information that must be reported on the 510(k) SUMMARY includes device identification, manufacturer details, intended use, technological characteristics, comparison to predicate devices, and summaries of any clinical studies or data.