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Page 3 of 10 ESTABLISHMENT REGISTRATION NUMBER to be provided by submitting company. July 8 1998 NEMA 510 k Submission Template Software DEVICE CLASS FDA has classi ed Magnetic Resonance Imaging Devices as Class II. Of the 510 k premarket noti cation submission. NEMA R L May 18 1998 Standardized MR Template for Software Submissions General format Cover Letter Table of Contents Attachment 1 optional FDA CDRH/ODE Division of Reproductive Abdominal Ear Nose and Throat and Radiological Devices...

How to fill out 510 k submission template

How to fill out 510(k) submission template:

Start with the basic information:

1. Enter the name and contact details of the submitter, including the company name, address, phone number, and email.
2. Specify the device name, model number, and intended use.
3. Provide the manufacturing location and any previous approvals or clearances obtained.

Identify the predicate device:

1. Select a predicate device that is similar to your own device and has already received FDA clearance.
2. Provide the predicate device's name, model number, and manufacturer.
3. Explain how your device is substantially equivalent to the predicate device in terms of intended use, technological characteristics, and performance.

Provide a description of the device:

1. Include detailed specifications of the device, such as materials used, dimensions, and any special features or functions.
2. Describe how the device is designed and how it functions.
3. Cover any labeling information, such as instructions for use or warnings.

Conduct a risk assessment:

1. Identify potential hazards associated with the device and its intended use.
2. Evaluate the severity and probability of harm from each hazard.
3. Describe risk control measures implemented to mitigate or eliminate risks.

Submit performance testing data:

1. Include any performance testing or validation studies conducted on the device.
2. Provide test protocols, results, and data analysis.
3. Explain how the testing demonstrates the device's safety and effectiveness.

Address biocompatibility:

1. Discuss the biocompatibility of the device, including any potential risks associated with patient contact.
2. Provide biocompatibility testing results, analysis, and documentation.

Prepare a summary of non-clinical and clinical testing:

1. Summarize any non-clinical testing performed, such as bench or laboratory testing.
2. Summarize any clinical testing performed, including study design, patient population, endpoints, and results.

Who needs a 510(k) submission template?

1. Medical device manufacturers planning to market a new medical device in the United States.
2. Companies seeking FDA clearance for modifications or technological enhancements to an existing device.
3. Individuals or organizations responsible for regulatory submissions and compliance.

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What is 510 k submission template?

The 510(k) submission template is a premarket submission made to the FDA to demonstrate that a new medical device is substantially equivalent to a predicate device already on the market.

Who is required to file 510 k submission template?

Any company intending to market a new medical device in the United States is required to file a 510(k) submission template.

How to fill out 510 k submission template?

To fill out a 510(k) submission template, the company must provide detailed information about the device, its intended use, how it functions, and comparison to the predicate device.

What is the purpose of 510 k submission template?

The purpose of the 510(k) submission template is to demonstrate that the new medical device is safe and effective for its intended use by showing its substantial equivalence to a legally marketed predicate device.

What information must be reported on 510 k submission template?

Information required on a 510(k) submission template includes device description, intended use, performance data, labeling, and a comparison to a predicate device.