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This document provides a summary of the 510(k) premarket notification for the Bionexia hCG Pregnancy Test, detailing regulatory information, product specifications, intended use, and performance standards.
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How to fill out 510k summary - accessdata
How to fill out 510(k) SUMMARY
01
Identify the device and its intended use.
02
Determine the appropriate predicate device.
03
Gather data to demonstrate substantial equivalence.
04
Complete the 510(k) form, providing all necessary information.
05
Include descriptions of manufacturing methods and labeling.
06
Submit any applicable testing results and clinical data.
07
Provide the signature of an authorized representative.
Who needs 510(k) SUMMARY?
01
Manufacturers of medical devices intended for marketing in the U.S.
02
Companies wishing to modify existing medical devices.
03
Entities seeking to introduce new devices that are similar to existing ones.
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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 contains information about a medical device seeking market clearance, demonstrating that the device is substantially equivalent to a legally marketed device.
Who is required to file 510(k) SUMMARY?
Manufacturers of medical devices that are not exempt and wish to market their devices in the U.S. must file a 510(k) SUMMARY.
How to fill out 510(k) SUMMARY?
To fill out the 510(k) SUMMARY, manufacturers should provide detailed descriptions of the device, including its intended use, technological characteristics, and comparisons to similar devices, along with any relevant testing data.
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 device's safety and effectiveness and to establish that it is substantially equivalent to a predicate device.
What information must be reported on 510(k) SUMMARY?
The information that must be reported includes the manufacturer's information, device description, intended use, technological comparison to predicate devices, summary of performance testing, and any labeling information.
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