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This document outlines the 510(k) premarket notification for the Psychemnedics Microplate ETA, an enzyme immunoassay device intended for the preliminary qualitative detection of opiates in hair samples.
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How to fill out 510 k summary
How to fill out 510 K SUMMARY
01
Begin with a clear title and summary of the device.
02
Describe the intended use and indications for use.
03
Provide a detailed description of the device, including its components and materials.
04
Outline the technological characteristics and compare with a predicate device.
05
Include any relevant labeling information.
06
Discuss the non-clinical and clinical data provided to support safety and effectiveness.
07
Conclude with any post-market surveillance plans, if applicable.
Who needs 510 K SUMMARY?
01
Manufacturers seeking FDA clearance for medical devices.
02
Companies developing new products that are significantly similar to existing devices.
03
Organizations looking to market a device in the United States.
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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 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.
What is the 510k 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 5 10k approval process?
There are three types of 510(k) submissions: Traditional, Abbreviated, and Special. Each type has its own requirements and may be appropriate for different types of medical devices. Traditional, Special, and Abbreviated 510(k)s require the same user fee.
What are the requirements for 510k clearance?
The FDA 510k submission requirements include extensive technical documentation such as proposed labeling, sterilization and shelf life data, biocompatibility research, animal, clinical and bench performance testing and other technical evidence needed to establish substantial equivalence and receive FDA 510k clearance.
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).
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.
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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, and is substantially equivalent to a legally marketed device.
Who is required to file 510 K SUMMARY?
Manufacturers of medical devices that wish to market their products in the United States and claim substantial equivalence to an already 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 complete a form that includes device information, the intended use, a description of the design, guidelines for the device's performance, and comparative data regarding the predicate device.
What is the purpose of 510 K SUMMARY?
The purpose of the 510(k) Summary is to ensure that the medical device is safe and effective for its intended use while providing a regulatory pathway for the approval of new devices.
What information must be reported on 510 K SUMMARY?
The 510(k) Summary must include device name, intended use, predicate device details, description of the device, labeling, performance data, and statements regarding safety and effectiveness.
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