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This document serves as a premarket notification for the LogicScan 64 and LogicScan 128 ultrasound imaging systems, detailing their classification, intended use, performance standards, and safety
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How to fill out 510k premarket submission
How to fill out 510(k) Premarket Submission
01
Determine if your device is Class I, II, or III to establish if a 510(k) is necessary.
02
Identify the predicate device that your device is substantially equivalent to.
03
Prepare a detailed description of your device, including its intended use and technological characteristics.
04
Compile performance data to demonstrate substantial equivalence, including bench testing, animal studies, or clinical data if needed.
05
Complete the 510(k) application form and include all required documents such as labeling, risk analysis, and manufacturing information.
06
Pay the required user fee associated with the 510(k) submission if applicable.
07
Submit the complete 510(k) package electronically or by mail to the FDA.
08
Respond promptly to any requests for additional information from FDA during their review process.
Who needs 510(k) Premarket Submission?
01
Manufacturers of medical devices that are classified as Class II, and some Class I devices that require 510(k) clearance in the United States.
02
Companies seeking to market a device that is similar to an already legally marketed device (predicate) and can demonstrate substantial equivalence.
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People Also Ask about
When to submit a 510 K premarket notification?
Manufacturers are required to submit a new 510(k) when a change (or changes) exceeds the 21 CFR 807.81(a)(3) threshold, “could significantly affect the safety or effectiveness of the device,” or constitutes a “major change or modification in the intended use of the device.” This significant effect could be positive or
When to submit a new 510k guidance?
Manufacturers are required to submit a new 510(k) when a change (or changes) exceeds the 21 CFR 807.81(a)(3) threshold, “could significantly affect the safety or effectiveness of the device,” or constitutes a “major change or modification in the intended use of the device.” This significant effect could be positive or
How much does a 510 K submission cost?
How Much Does a FDA 510k Approval Cost? The vast majority of our FDA 510K clients generally spend in the range of $20,000-$30,000 to have their product or device prepared and reviewed before the actual FDA 510k submission process.
What is the FDA premarket approval number 510k?
A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval.
What is the difference between premarket notification and 510k?
These two pathways determine the speed, complexity, and cost of your product's approval. While 510(k) clearance is used for most Class II devices with existing market equivalents, PMA (Premarket Approval) is required for high-risk or entirely novel Class III products.
What is the difference between premarket notification and 510k?
These two pathways determine the speed, complexity, and cost of your product's approval. While 510(k) clearance is used for most Class II devices with existing market equivalents, PMA (Premarket Approval) is required for high-risk or entirely novel Class III products.
When to submit abbreviated 510 k?
Manufacturers can choose to submit an Abbreviated 510(k) when the submission relies on FDA guidance document(s), demonstration of compliance with special control(s) for the device type, or voluntary consensus standard(s).
What is 510 K premarket notification requirements?
A 510(k) Premarket Notification is required for low to moderate risk medical devices classified as either Class I or Class II and not exempt from 510(k). Companies are unable to market their products to health care providers, patients and other consumers until they are given 510(k) clearance by the FDA.
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What is 510(k) Premarket Submission?
The 510(k) Premarket Submission is a premarket submission made to the FDA to demonstrate that the device to be marketed is safe and effective and is substantially equivalent to a legally marketed device.
Who is required to file 510(k) Premarket Submission?
Manufacturers of medical devices that are intended for human use and that are not exempt from premarket notification requirements are required to file a 510(k) Premarket Submission.
How to fill out 510(k) Premarket Submission?
To fill out the 510(k) Premarket Submission, manufacturers must complete the FDA's 510(k) application form and provide information about the device, including its intended use, technological characteristics, and performance data, among other requirements.
What is the purpose of 510(k) Premarket Submission?
The purpose of the 510(k) Premarket Submission is to ensure that new devices are safe and effective for public use and to facilitate the entry of new devices into the market by establishing their substantial equivalence to existing devices.
What information must be reported on 510(k) Premarket Submission?
The 510(k) Premarket Submission must report information such as the device's name, description, intended use, manufacturing information, substantial equivalence claims, and any applicable performance testing results.
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