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A summary of 510(k) safety and effectiveness information regarding the Comprehensive® Segmental Revision System intended for use in upper extremity joint replacements, addressing needs related to
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How to fill out 510k summary - accessdata
How to fill out 510(k) SUMMARY
01
Identify the medical device that requires a 510(k) submission.
02
Gather all necessary device information, including product details and intended use.
03
Review the FDA's guidance document on 510(k) submissions to understand specific requirements.
04
Prepare a summary of the device, including description, indications for use, and technological characteristics.
05
Include any performance data or testing results that supports the safety and efficacy of the device.
06
Provide a comparison to a legally marketed predicate device in terms of safety and effectiveness.
07
Ensure that the submission complies with all regulatory requirements and format guidelines.
08
Compile the 510(k) summary into a single document for submission to the FDA.
Who needs 510(k) SUMMARY?
01
Manufacturers of medical devices that are not exempt from premarket notification requirements.
02
Companies looking to market a new medical device that is substantially equivalent to a predicate device.
03
Organizations intending to introduce modifications to an existing medical device that require a new submission.
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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?
The 510(k) SUMMARY is a document submitted to the FDA that provides information about a medical device and demonstrates 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 a new device that is not exempt from premarket notification must file a 510(k) SUMMARY with the FDA.
How to fill out 510(k) SUMMARY?
To fill out a 510(k) SUMMARY, manufacturers must follow the FDA's guidance document, providing detailed information about the device, its intended use, and evidence supporting its equivalence to a predicate device.
What is the purpose of 510(k) SUMMARY?
The purpose of the 510(k) SUMMARY is to inform the FDA about the safety and effectiveness of a medical device and to establish its equivalence to an already approved device.
What information must be reported on 510(k) SUMMARY?
The 510(k) SUMMARY must include information such as device name, intended use, description of the device, comparison to predicate devices, and results from any testing or clinical studies.
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