Need help getting your

Radiation-Emitting
Electronic Device (RED)
compliant?

Importing REDs comes with a lot of regulatory processes and paperwork, from designating local representatives to obtaining an FDA Accession Number and submitting product reports. That’s where Registrar Corp comes in. With over 20 years of experience guiding domestic and foreign manufacturers through FDA compliance, we can help get your product to the U.S. market.

red-services

Registrar Corp RED Services

We’re here to be your local compliance team so you can meet all RED regulatory requirements. Our services for RED manufacturers, assemblers, and importers include:

Designated U.S. Agent for Service of Process

Product and Annual Report preparation and submission

FDA Accession Number support

U.S. Agent

U.S. Agents for Service of Process act as representatives of foreign manufacturers by receiving any U.S. legal documents served to the manufacturer. With Registrar Corp, you’ll get a dedicated agent who will promptly forward any documentation in the case of legal action, so you can respond promptly.

FDA Accession Number

Your FDA Accession Number, or unique report identification number, will be required to fill out import documents at port of entry. We can work with you to obtain your FDA Accession Number and guide you through the import process quickly and efficiently.

Product Report Submission

Before your REDs are shipped or transported, you must submit a Product Report to FDA’s Center for Devices and Radiological Health (CDRH). You’ll also need to create an Annual Report each year your products are on the market. Registrar Corp’s team of professionals can help you maintain RED records and organize, prepare, and submit regular product reports.

product-report

Get assistance with RED services.

Frequently Asked Questions

REDs are defined by FDA as any product that contains an electronic circuit and generates any kind of radiation, such as X radiation (x-rays), microwaves, radio waves (radiofrequency (RF)), laser, visible light, sound, ultrasound, or ultraviolet light. Some examples of REDs include diagnostic x-ray systems, laser products, laser light shows, and microwave ovens.

Legal terms and definitions for REDs can be found here.

Yes, manufacturers must maintain records of their REDs and submit reports to FDA’s Center for Devices and Radiological Health (CDRH). Specific reporting and record keeping requirements and information can be found in Table 1 of Title 21 of the Federal Code of Regulations and on the FDA website.

RED product, supplemental, or abbreviated reports must be submitted before products are imported into the U.S. or before transporting the product across state lines if it is domestic. Reports for imported products must be sent at least one month before shipment.

Annual RED reports are due annually on September 1 and should cover production for the U.S. from July 1 of the previous year to June 30 of the current year.

Early report submissions allow the CDRH time to contact you about potential issues and provide an acknowledgment of receipt letter which includes a unique identification number for your report, or Accession Number.

No, an FDA Accession Number only means that your report has been received and processed into the CDRH Document Control Center (DCC) database.

No, but you do need to produce the Accession Number at port of entry, or your shipment will be detained. The acknowledgment letter and Accession Number are considered evidence that your report was received by CDRH and companies importing REDs will need to include their Accession Number on the import affirmation form, FDA 2877.

Depending on the device model variations that are being imported and the technology within the devices (e.g. laser and x-ray devices in a single shipment), you may need to produce two or more Accession Numbers at port of entry.

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