Compliance and registration services

for other industries.

We help keep your industry compliant. Registrar Corp offers FDA regulatory support services to electronics or radiation-emitting devices (RED), tobacco, and biologics manufacturers.

Electronics or Radiation Emitting Devices (REDs)

Stay on top of FDA requirements for REDs. Registrar Corp supports electronics manufacturers by offering FDA compliance services including Designated U.S Agent for Service of Process, FDA Accession Number support, label reviews, and annual and product report submission.

Tobacco

Register your tobacco products to enter the U.S. market. Our team of regulatory professionals can assist you with FDA establishment registration and renewal, product listing submissions, and ingredient reporting.

Biologics

Whether you manufacture allergenics, blood products, or vaccines, Registrar Corp can help you stay compliant with FDA. We support biologics companies with Blood Establishment FDA Registration, annual renewal, and registration and listing for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).

Work with Registrar Corp today.

With 20 years of experience, we’re committed to helping your company achieve FDA compliance.

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.

FDA Entry Reviewers use the information provided to FDA by importers before entry, which includes:

  • Declared Manufacturer
  • Product Description
  • Affirmations of Compliance (A of C)

These entry declarations are then verified for compliance by comparing them with the information in FDA’s internal data systems.

Yes. Medical REDs must also meet FDA regulations for medical devices as well as RED regulations.

The FDA defines “tobacco product” as “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).”

This may include, but is not limited to, e-cigarettes, cigars, hookah tobacco, pipe tobacco, and roll your own (RYO) tobacco.

The FDA will verify compliance with the following requirements for tobacco products at the time of importation:

  • Market Authorization
  • Labeling
  • User Fees

The FDA examines tobacco product labels to confirm regulatory compliance. Tobacco product labels, labeling, or advertising will be reviewed for:

  • General labeling requirements
  • Nicotine warning
  • Modified risk descriptors such as “low,” “mild,” or “light,” or similar descriptors and no FDA order in effect
  • Advertising warnings for smokeless tobacco
  • Labeling for therapeutic purposes
  • Artificial or natural flavors (other than tobacco or menthol) or an herb or spice that is a characterizing flavor of the tobacco product or tobacco smoke
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