Get Fda 3636 2020-2025

Filling out the FDA 3636 form accurately ensures compliance with federal regulations for laser and laser light show products. This guide provides clear, step-by-step instructions to assist users in completing the form online efficiently.

Follow the steps to successfully complete the FDA 3636 form.

1. Click ‘Get Form’ button to obtain the form and open it in the online editor.
2. Identify the manufacturer: In this section, input your company name, address, and contact details. Sign where indicated and specify the reporting period by filling in the years.
3. Specify the production status: Check the applicable statement regarding your products. Indicate whether products were manufactured, if the firm is still in business, or if it is out of business.
4. Provide current production data: For all laser products, complete the relevant sections, including accession numbers and production statuses. If necessary, utilize additional sheets for clarity.
5. Summarize quality control procedures: Confirm that you maintain written procedures for quality control and testing, and check the appropriate answer based on your current procedures.
6. Document test results: For each model or show produced, indicate the number of units tested for performance requirements, label compliance, and any light show variance conditions.
7. Compile correspondence records: Maintain records of communications relating to radiation safety, and complete the corresponding section with relevant summaries or attachments.
8. Finalize distribution records: Provide information on how products can be traced from your records to ensure compliance with distribution regulations.
9. Once all sections are filled out accurately, save changes, and prepare to download, print, or share the completed form as needed.

Complete your FDA 3636 form online today to ensure compliance with federal regulations.