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FIRST CIRCULAR of the 2014 INDIGO CONFERENCE 39th INDIGO SYMPOSIUM Ashlar Conference Grounds, Pacific Grove, California, USA Sunday, 6 July (p.m.) Thursday, 10 July 2014 This INDIGO meeting is sponsored
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How to fill out 710 k
How to Fill Out 710 k:
01
Gather all necessary information: Before filling out the form 710 k, make sure you have all the required information, such as your company's name, address, contact details, and the specific medical device you are seeking clearance for.
02
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03
Provide accurate device information: Fill in the form with accurate and detailed information regarding the medical device you wish to get clearance for. Be sure to include its intended use, specifications, and any relevant scientific or engineering data.
04
Explain the device technology: Clearly explain the technology used in the medical device and how it differs from existing devices in the market. Provide evidence to support claims related to safety and effectiveness.
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Conduct a thorough risk assessment: Evaluate the potential risks associated with the device and provide a comprehensive analysis in the form. Include any measures taken to mitigate those risks.
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Include supporting documentation: Attach any necessary supporting documentation, such as test reports, clinical trials data, or performance evaluations, to strengthen your application.
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Submit the form: Once you have filled out the form and gathered all the required documents, submit your completed 710 k to the appropriate regulatory authority, typically the United States Food and Drug Administration (FDA).
Who needs 710 k:
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Medical device manufacturers: Any company or individual seeking to introduce a new medical device or change an existing device's intended use may need to submit a 710 k.
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Developers of new technological advancements: If you have developed a medical device that incorporates innovative technologies or features, you may need to file a 710 k to seek clearance from the regulatory authority.
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Companies seeking FDA clearance: In the United States, the FDA requires medical device manufacturers to obtain clearance for certain devices before they can be legally marketed and sold. Therefore, companies aiming to market their medical devices in the US may need to submit a 710 k.
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What is 710 k?
710 k is a premarket submission made to the FDA to demonstrate that a new medical device is substantially equivalent to a legally marketed device.
Who is required to file 710 k?
Manufacturers of medical devices seeking marketing approval in the United States are required to file a 710 k.
How to fill out 710 k?
The 710 k submission process involves providing information on the new medical device's indications for use, design, materials, performance, and labeling compared to a predicate device.
What is the purpose of 710 k?
The purpose of the 710 k process is to demonstrate that a new medical device is safe and effective for its intended use.
What information must be reported on 710 k?
Information such as device description, intended use, labeling, performance data, and comparisons to a predicate device must be reported on a 710 k.
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