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A summary of safety and effectiveness information related to the Vanguard® Asymmetrical Patellar Component, submitted for FDA clearance under the 510(k) process.
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How to fill out 510k summary - accessdata
How to fill out 510(k) SUMMARY
01
Identify the device you are seeking to market and ensure it is a medical device as defined by the FDA.
02
Determine if your device is substantially equivalent to a legally marketed device (predicate device).
03
Gather all necessary data and information, including device description, intended use, technological characteristics, and performance testing results.
04
Prepare a summary of safety and effectiveness that includes information about the predicate device.
05
Complete the 510(k) Form and provide all required documentation.
06
Submit the 510(k) application electronically or via mail to the FDA.
07
Respond promptly to any requests for additional information from the FDA during their review process.
Who needs 510(k) SUMMARY?
01
Manufacturers of medical devices seeking to market their products in the United States.
02
Companies that have developed a new medical device or made modifications to an existing one that may affect safety or effectiveness.
03
International manufacturers who want to market their devices in the U.S. and need to demonstrate substantial equivalence to existing products.
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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 document submitted to the FDA that provides information about a medical device, demonstrating that it is substantially equivalent to a legally marketed device.
Who is required to file 510(k) SUMMARY?
Manufacturers of medical devices intending to market in the U.S. are required to file a 510(k) Summary if their device is not exempt from premarket notification and is intended for human use.
How to fill out 510(k) SUMMARY?
To fill out a 510(k) Summary, manufacturers must complete specific forms provided by the FDA, include detailed descriptions of the device, intended use, technological characteristics, and risk analysis.
What is the purpose of 510(k) SUMMARY?
The purpose of a 510(k) Summary is to inform the FDA and the public about the device's safety and effectiveness compared to predicate devices to ensure regulation compliance.
What information must be reported on 510(k) SUMMARY?
The 510(k) Summary must include device name, intended use, descriptions of physical and technical characteristics, performance data, and any labeling information.
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