Get Fda Form 3636

Filling out the FDA Form 3636 online requires careful attention to detail. This guide provides step-by-step instructions to help you navigate each section of the form, ensuring you meet the necessary reporting requirements for radiation safety testing of laser and laser light show products.

Follow the steps to complete the form accurately.

1. Use the 'Get Form' button to access the form and open it in your preferred editor.
2. In Part 1, provide the identification details of the manufacturer including the report date, company name, address, and the signature of the corresponding official.
3. In Part 2, indicate the production status by checking the appropriate box that reflects whether products were manufactured during the reporting period.
4. Complete Part 3 by providing the current production tabulation. Enter the accession number, family designation, product function, and production status for all laser products.
5. In Part 4, provide information regarding the procedures for quality control and testing. Confirm if the procedures are up-to-date and accurate.
6. In Part 5, summarize the test results for each model or show produced. Include the number tested for performance requirements and labels.
7. Fill out Part 6 regarding correspondence concerning radiation safety. Document the number of relevant communications and attach necessary copies.
8. Complete Part 7 by maintaining the distribution records. Indicate how products can be traced from these records.
9. Once all sections are completed, save the changes, and prepare the document for submission. You will also have the option to download, print, or share the final report.

Complete your FDA Form 3636 online today to ensure your compliance with reporting requirements.