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510(k) Notification Submission Abbreviated Intel Health Guide Express 510(k) Summary FBS2r As required by 21 CFR 807.92© Submitter 5 10(k) Owner: Address: Telephone: Contact Person: Date Prepared:

How to fill out 21 cfr 807 92

How to fill out 21 CFR 807 92?

1. Begin by reviewing the requirements outlined in 21 CFR 807 92. Familiarize yourself with the specific sections and provisions that apply to your situation.
2. Gather all necessary information and documentation required to complete the form. This may include product details, manufacturing processes, labeling information, and any other relevant data.
3. Carefully read through the instructions provided with the form. Ensure that you have a clear understanding of each question and what information is being requested.
4. Start filling out the form by providing the requested information in the appropriate fields. Be as accurate and precise as possible, as the information provided will be used for regulatory purposes.
5. Pay close attention to any specific formatting or formatting requirements specified in the instructions. This may include using specific units of measurement, date formats, or labeling requirements.
6. Double-check all the information provided before submitting the form. Verify that there are no errors, omissions, or inconsistencies in the data provided.
7. If any supporting documentation or attachments are required, ensure that they are appropriately labeled and included with the completed form.

Who needs 21 CFR 807 92?

1. Medical device manufacturers: 21 CFR 807 92 applies to manufacturers who intend to market their medical devices in the United States. Compliance with this regulation ensures that the devices meet the required safety and effectiveness standards.
2. Importers of medical devices: Importers who bring medical devices into the United States are also subject to the provisions of 21 CFR 807 92. They need to fill out the form to provide the necessary information about the imported products.
3. Distributors and resellers: Distributors and resellers of medical devices may need to familiarize themselves with 21 CFR 807 92 to ensure they are distributing products that comply with the applicable regulatory requirements.

In summary, filling out 21 CFR 807 92 requires a thorough understanding of the provided instructions, accurate data entry, and compliance with the specific requirements outlined in the regulation. It is primarily applicable to medical device manufacturers, importers, distributors, and resellers operating in the United States.

For pdfFiller’s FAQs

What is 21 cfr 807 92?

21 CFR 807.92 refers to the regulation that outlines the requirements for submitting a premarket notification (510(k)) for medical devices to the FDA.

Who is required to file 21 cfr 807 92?

Manufacturers of medical devices who intend to introduce a new device to the market are required to file a premarket notification (510(k)) in accordance with 21 CFR 807.92.

How to fill out 21 cfr 807 92?

To fill out 21 CFR 807.92, manufacturers need to provide detailed information about the new medical device, including its intended use, design, performance, and data supporting its safety and effectiveness.

What is the purpose of 21 cfr 807 92?

The purpose of 21 CFR 807.92 is to ensure that new medical devices are safe and effective for their intended use before they are marketed to the public.

What information must be reported on 21 cfr 807 92?

The information that must be reported on 21 CFR 807.92 includes device description, classification, indications for use, summary of design controls, and any clinical data supporting the device's safety and effectiveness.

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