Devices that emit radiation, including X-ray machines, lasers, ultrasound equipment, tanning lamps, and microwave ovens, are regulated by the FDA under 21 CFR Parts 1000–1050. Manufacturers, importers, and distributors must comply with strict registration, reporting, and safety requirements to ensure public health and avoid regulatory enforcement actions.

At XPRO AMERICA, we provide end-to-end support for companies producing or distributing radiation-emitting electronic products, ensuring full FDA compliance and smooth market access.

Key Services:

• Device Registration: All domestic and foreign manufacturers of radiation-emitting products must register with the FDA and obtain product listing information. Our team manages registration to ensure accurate facility and device records.
• Radiation Safety Reporting (Accession Numbers): Manufacturers must provide radiation safety information to the FDA, including product performance testing and compliance with applicable safety standards. XPRO AMERICA prepares, validates, and submits this data to obtain Accession Numbers for each product.
• Product & Annual Reports Submission: FDA requires regular product reporting and annual updates for radiation-emitting devices. We assist in preparing, reviewing, and submitting these reports to ensure ongoing compliance.
• Labeling & Regulatory Guidance: Proper radiation safety labeling, instructions, and warnings are critical for compliance. XPRO AMERICA reviews labeling to ensure adherence to FDA requirements and reduce liability.

Why Choose XPRO AMERICA?

• Expertise in FDA regulations for all radiation-emitting electronic products.
• End-to-end support from registration to annual reporting and labeling.
• Accurate preparation and submission of radiation safety documentation.
• Minimizes regulatory risk and ensures uninterrupted market access.

By partnering with XPRO AMERICA, manufacturers and distributors of radiation-emitting devices can confidently meet FDA requirements, maintain up-to-date registrations, and submit accurate radiation safety reports. Our comprehensive services streamline compliance, reduce administrative burden, and safeguard public safety while facilitating efficient market entry.

XPRO AMERICA ensures FDA compliance for radiation-emitting products with registration, safety reporting, and annual product submissions.