FDA Radiation-Emitting Device Reporting
Electronic products that emit radiation — such as lasers, x-ray equipment, and ultrasound devices — are subject to FDA reporting requirements. Manufacturers must file reports with FDA before marketing these devices in the U.S.
At USAgentPros, we help companies meet FDA’s radiation-emitting device (RED) reporting rules with accuracy and ease.
Who Must Report?
FDA requires reporting for many categories, including:
- X-ray machines and CT scanners
- Ultrasound devices
- Lasers and LED devices
- Microwaves and industrial equipment
- Other radiation-emitting electronic products
Our RED Compliance Services
- FDA Establishment Registration for RED manufacturers
- Product Report preparation and submission
- U.S. Agent representation for foreign manufacturers
- Ongoing support for supplemental reports or product changes
Why It Matters
Failure to submit required reports can lead to:
- FDA import detentions
- Enforcement actions or fines
- Delays in launching your devices into the U.S. market
Why Work With USAgentPros?
Dedicated Compliance Pro – An expert guiding every submission
Fast Turnarounds – Keep your devices moving into the U.S.
100% Money-Back Guarantee – Confidence built into every project
Competitive Pricing – Trusted compliance at a fair price
Stay Compliant with FDA RED Reporting
Don’t risk delays or penalties. Partner with USAgentPros for radiation-emitting device reporting you can trust.