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How to fill out the FDA 3636 online
Completing the FDA 3636 form is essential for manufacturers of laser and laser light show products to report on radiation safety testing. This guide will take you through the necessary steps to ensure your report is filled out accurately and submitted correctly.
Follow the steps to successfully complete the FDA 3636 form online.
- Click ‘Get Form’ button to obtain the form and open it in the editor.
- Begin by filling in Part 1, which requires identification of the manufacturer. Provide your company name, address, and contact information. Ensure the 'Report Date' and 'Years in Reporting Period' are correctly entered.
- Move on to Part 2, where you must indicate your production status. Check the statement that applies to your firm and take the indicated action based on your operational status during the reporting period.
- In Part 3, provide details regarding your current production of laser products. Complete Section 3.1 for all laser products and Section 3.2 if applicable for laser light shows. Include necessary details such as accession numbers and production status.
- For Part 4, check that your quality control and testing procedures are up-to-date. You must verify the adequacy of your quality control procedures and test results for compliance.
- In Part 5, summarize your test results. Review your quality control records and indicate the number of units tested, ensuring all compliance requirements are documented.
- Proceed to Part 6 to summarize correspondence concerning radiation safety. Count and attach any relevant documentation reflecting communications regarding radiation exposure or product issues.
- Finally, complete Part 7, where you will maintain distribution records and confirm how products can be traced from shipping records.
- After completing all parts, ensure to save your changes. You may then download, print, or share the form as needed.
Start your FDA 3636 form submission online today to ensure compliance and safety in your laser product operations.
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