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This document provides safety and effectiveness information for the GEMORE TENS System, a transcutaneous electrical nerve stimulator for pain relief, in accordance with FDA requirements.
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How to fill out 510k summary - accessdata
How to fill out 510(K) SUMMARY
01
Identify the device classification and the appropriate predicate device.
02
Prepare a detailed description of the device, including its intended use and technological characteristics.
03
Perform a comparison of the new device to the predicate device, highlighting similarities and differences.
04
Conduct necessary testing and include results to demonstrate safety and effectiveness.
05
Compile all information, including labeling and packaging details, into a comprehensive summary.
06
Submit the 510(k) summary electronically through the FDA's submission portal.
07
Respond to any additional requests or questions from the FDA regarding the submission.
Who needs 510(K) SUMMARY?
01
Manufacturers who intend to market a medical device in the United States.
02
Companies providing modifications to existing devices that may affect safety or effectiveness.
03
Importers of medical devices seeking clearance to sell in the U.S. market.
04
Entities looking to ensure compliance with FDA regulations for medical devices.
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People Also Ask about
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 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.
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.
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.
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 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.
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What is 510(K) SUMMARY?
The 510(k) summary is a document submitted to the FDA by medical device manufacturers to demonstrate that their device is safe and effective, and is substantially equivalent to a device already on the market.
Who is required to file 510(K) SUMMARY?
Manufacturers of medical devices who intend to market a new device or make modifications to an existing device that may significantly affect its safety or effectiveness are required to file a 510(k) summary.
How to fill out 510(K) SUMMARY?
To fill out a 510(k) summary, manufacturers must gather relevant information about their device, including a description of the device, its intended use, labeling, performance data, and any comparisons to predicate devices, and submit this information through the FDA's online submission system.
What is the purpose of 510(K) SUMMARY?
The purpose of the 510(k) summary is to provide the FDA with essential information to evaluate the safety and effectiveness of a medical device before it is marketed.
What information must be reported on 510(K) SUMMARY?
The information that must be reported on a 510(k) summary includes the device's name, intended use, descriptions, labeling, performance testing results, and any other information that demonstrates its substantial equivalence to a legally marketed device.
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