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This document summarizes the safety and effectiveness information for the Compact Digital Blood Pressure Monitor in accordance with FDA regulations.
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How to fill out 510k summary - accessdata
How to fill out 510(K) Summary
01
Identify the device you are submitting for 510(k) clearance.
02
Gather relevant information about the device, including its intended use and technological characteristics.
03
Determine the predicate device to which you are comparing your device.
04
Prepare a comparative analysis that highlights the similarities and differences between your device and the predicate device.
05
Compile data concerning the device's performance, safety, and effectiveness.
06
Draft the summary document including all required sections: device description, predicate comparison, summary of safety and effectiveness, and any other regulatory requirements.
07
Review the 510(k) summary to ensure accuracy and completeness.
08
Submit the 510(k) summary electronically through the FDA's submission portal.
Who needs 510(K) Summary?
01
Manufacturers of medical devices who intend to market their products in the United States.
02
Companies seeking FDA approval for devices that are substantially equivalent to an already marketed device.
03
Organizations involved in the design, development, or distribution of medical devices.
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People Also Ask about
What is the content of a special 510k?
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 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
How long does FDA 510 K approval take?
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 510 K process?
Most 510(k)s will include some type of performance data. The extent of performance data will depend on the complexity of the device and its intended use and indications. Performance data should be provided to help demonstrate SE of your device to one or more legally marketed devices (predicate device).
What is the rejection rate for 510k?
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.
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What is 510(K) Summary?
A 510(K) Summary is a document submitted to the FDA that provides details about a medical device demonstrating that it is safe and effective, and substantially equivalent to a device already approved for marketing.
Who is required to file 510(K) Summary?
Manufacturers of medical devices that are not exempt from premarket notification requirements and intend to market their devices in the U.S. must file a 510(K) Summary.
How to fill out 510(K) Summary?
To fill out a 510(K) Summary, manufacturers must provide specific information about the device, including its intended use, technological characteristics, and performance data, which may include laboratory and clinical study results.
What is the purpose of 510(K) Summary?
The purpose of the 510(K) Summary is to ensure that a new medical device is as safe and effective as an already marketed device, thereby facilitating quicker access to medical devices while maintaining regulatory standards.
What information must be reported on 510(K) Summary?
The information that must be reported on a 510(K) Summary includes the submitter's details, device identification, intended use, technological characteristics, comparison to predicate devices, and any relevant performance testing data.
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