FDA X-ray Report 2025: Submit by Sept 1 with IRSC Support
Jan 6
📅Deadline, Requirements, and IRSC Inc.’s Expert Support
If you manufacture x-ray components or radiological devices, you are required to submit the FDA X-ray Annual Report 2025 by September 1. This annual filing, mandated under FDA Regulation 21 CFR 1002.11, ensures that your equipment meets federal radiation safety standards.
📝 What’s Required for the Annual FDA X-ray Report?
The submission must cover data from July 1, 2024 to June 30, 2025. You’ll need to provide:
A completed FDA Form 3641
Test result documentation
An overview of radiation safety procedures
⚠️ Why This Report Matters
Submitting your report helps the FDA:
Review your product safety procedures
Identify potential risks or device issues
Plan inspections and take enforcement action when needed
🔧 IRSC Makes FDA Report Submissions Easy
IRSC Inc. helps businesses like yours navigate the X-ray report process—saving you time, stress, and the risk of non-compliance.
Our expert support includes:
FDA Form 3641 preparation
Guidance on required documentation
Personalized consulting to avoid delays
Deadline tracking and submission management
🧠 Stay Compliant and Focus on Your Business
Let us handle the technicalities while you focus on innovation. We help ensure your report is accurate, complete, and filed on time—every time.
