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This document is a summary of the 510(k) premarket notification for the Thumper® Model 1008, a mechanical cardiopulmonary resuscitation device intended for use on adult patients in cases of clinical
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How to fill out 510k summary
How to fill out 510(k) SUMMARY
01
Identify the device and its intended use.
02
Gather device description, including specifications and materials.
03
Determine the predicate device to demonstrate substantial equivalence.
04
Prepare the comparison summary between your device and the predicate device.
05
Collect clinical and non-clinical data supporting your device's safety and effectiveness.
06
Complete the FDA's 510(k) form, providing all required information.
07
Review and compile labeling information for the device.
08
Submit the 510(k) summary along with the application to the FDA.
Who needs 510(k) SUMMARY?
01
Manufacturers of medical devices that seek to market their products in the U.S.
02
Companies introducing modifications or new indications for existing devices.
03
Importers of medical devices requiring clearance from the FDA.
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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 evidence that a medical device is safe and effective, demonstrating that it is substantially equivalent to a device already on the market.
Who is required to file 510(k) SUMMARY?
Manufacturers of certain medical devices that are not exempt and seek to demonstrate substantial equivalence to a legally marketed 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 about the device, including its intended use, technological characteristics, performance data, and any relevant labeling information, following the FDA's guidance.
What is the purpose of 510(k) SUMMARY?
The purpose of the 510(k) SUMMARY is to inform the FDA and the public about the safety and efficacy of a medical device prior to its market entry.
What information must be reported on 510(k) SUMMARY?
The 510(k) SUMMARY must include information such as device name, manufacturer name, description of the device, intended use, performance data, and comparisons to predicate devices.
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