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This document provides a summary of the 510(k) safety and effectiveness information for the Maestro® Wrist Plating System, including details of the device, its intended use, and performance data.
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How to fill out 510k summary - accessdata
How to fill out 510(k) SUMMARY
01
Determine if your device is subject to 510(k) submission based on its classification.
02
Identify a predicate device that is substantially equivalent to your device.
03
Gather necessary data on your device, including technical specifications, performance testing results, and labeling information.
04
Complete the FDA 510(k) application form, ensuring all sections are filled accurately.
05
Prepare a summary of your device, including intended use, design, manufacturing process, and comparison to predicate.
06
Compile and attach supporting documentation, including risk assessments and any clinical data.
07
Submit the 510(k) application electronically through the FDA’s submission portal.
08
Pay any applicable user fees associated with the submission.
09
Respond to any FDA requests for additional information or clarification.
Who needs 510(k) SUMMARY?
01
Manufacturers of medical devices that are not exempt from 510(k) requirements.
02
Companies seeking FDA clearance for devices that are substantially equivalent to existing marketed devices.
03
Businesses introducing new medical technologies that fall under FDA regulations.
04
Distributors of medical devices looking to ensure compliance with FDA standards.
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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.
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What is 510(k) SUMMARY?
A 510(k) SUMMARY is a premarket submission made to the FDA to demonstrate that a medical device is safe and effective, or substantially equivalent to a legally marketed device.
Who is required to file 510(k) SUMMARY?
Manufacturers proposing to market a medical device that is not exempt from premarket notification requirements must file a 510(k) SUMMARY.
How to fill out 510(k) SUMMARY?
To fill out a 510(k) SUMMARY, manufacturers must provide detailed information about the device, including its intended use, principles of operation, labeling, standards, and comparisons to predicate devices.
What is the purpose of 510(k) SUMMARY?
The purpose of the 510(k) SUMMARY is to allow the FDA to assess whether a device is safe and effective for its intended use and to ensure it is substantially equivalent to an existing device.
What information must be reported on 510(k) SUMMARY?
The 510(k) SUMMARY must include device description, indications for use, technological characteristics, performance data, and labeling information, as well as comparisons to predicate devices.
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