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AUTOIMMUNE US FEB 2 62014 PREMARKET NOTIFICATION 510(K) SAFETY AND EFFECTIVENESS SUMMARY (as required by 21 CFR 807.92) A. 610(k)Number: K13 1791 B. Purpose for Submission: New device C. Measured:

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How to fill out summary - FDA:

1. Begin by carefully reading the guidelines and requirements provided by the FDA for filling out the summary. Make sure you understand the information they are looking for and how they want it to be presented.
2. Start with the basic information section. Include the title of the drug or medical device that is being summarized, the name of the company or manufacturer, and any relevant identification numbers or codes.
3. Provide a concise summary of the purpose and objectives of the drug or medical device. Explain what it is intended to treat or diagnose, and highlight any unique features or benefits.
4. Include a description of the key findings from clinical studies or trials conducted on the drug or medical device. Summarize the results in a clear and understandable manner, highlighting any statistically significant outcomes or safety concerns.
5. Discuss the potential risks and side effects associated with the use of the drug or medical device. This should include information on known adverse reactions, contraindications, and precautions that need to be taken.
6. Provide information on the proper dosage and administration of the drug or medical device. Include any special instructions or considerations that need to be followed, such as timing of administration or requirements for monitoring.
7. If applicable, include information on any post-market surveillance or ongoing studies that are being conducted on the drug or medical device. This can help demonstrate the commitment to monitoring safety and effectiveness even after it has been approved.
8. Finally, review the summary for accuracy and completeness. Make sure all the required information has been included and that the content is clear and understandable.

Who needs summary - FDA?:

1. Pharmaceutical companies and manufacturers who are seeking FDA approval for a new drug or medical device need to provide a summary to the FDA. This is part of the regulatory process to ensure that the product meets safety and effectiveness standards.
2. Physicians and healthcare professionals may also need access to the FDA summary to stay informed about the latest drugs or medical devices that have been approved. They can use this information to make informed decisions about treatment options for their patients.
3. Patients and consumers can also benefit from reading the FDA summary to understand the basic information, potential risks, and benefits of a particular drug or medical device. It allows them to make informed decisions and have discussions with their healthcare providers about their treatment options.

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What is summary - fda?

Summary - FDA stands for Summary of Food and Drug Administration. It is a report that summarizes the information related to food and drug activities.

Who is required to file summary - fda?

Manufacturers, distributors, and importers of food and drug products are required to file the summary - FDA.

How to fill out summary - fda?

The summary - FDA can be filled out online through the official website of the Food and Drug Administration.

What is the purpose of summary - fda?

The purpose of summary - FDA is to provide a snapshot of the food and drug activities to ensure compliance with regulations and guidelines.

What information must be reported on summary - fda?

The information that must be reported on the summary - FDA includes details of products, manufacturing processes, distribution channels, and any adverse events.