Get the free FDA 2877

This form is used for declaring imported electronic products subject to radiation control standards for entry into the U.S. It includes instructions for submission, product details, and compliance

How to fill out fda 2877

How to fill out FDA 2877

1. Begin by downloading FDA Form 2877 from the FDA's official website.
2. Fill out the 'Applicant Information' section with your name and contact details.
3. Provide the 'Importer's Information' if applicable, including their name and address.
4. Complete the 'Product Information' section with details about the product being imported or exported.
5. Specify the basis for submitting the form in the 'Purpose' section.
6. Sign and date the form at the designated area.
7. Submit the completed form to the FDA as per their submission guidelines.

Who needs FDA 2877?

1. Individuals or companies that are importing or exporting food products into or out of the United States.
2. Manufacturers and distributors of food products are required to fill out FDA 2877 for compliance with regulatory requirements.

People Also Ask about

Are radiation emitting products regulated by the FDA?

Introduction. FDA regulates radiation emitting electronic products. The purpose is to prevent unnecessary exposure to radiation due to the use of these products.

Are LEDs regulated by the FDA?

Although there is no performance standard for LEDs, they do require reporting to FDA, the same as any other radiation-emitting product.

What type of products does the FDA regulate?

FDA is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices. FDA also has the responsibility in maintaining the safety of our nation's food supply (human and animal), cosmetics, and products that emit radiation.

What is the FDA form 2877?

FDA-2877 is for components/equipment with laser or X-ray type of radiation, and FDA governs all of those. If you import resin-type 3D printer that uses a laser as the light source, you must submit FDA-2877.

What is the US version of FDA?

The U.S. Food and Drug Administration is a federal regulatory agency in the Department of Health and Human Services.

Which product is not regulated by the FDA?

The FDA does not regulate alcohol, illegal drugs, and meat and poultry. Additionally, dietary supplements are regulated differently from prescription or over-the-counter drugs by the FDA. Animal feeds & medications, biological products, cosmetics, and medical devices are also examples of products regulated by the FDA.

Is radiation therapy FDA regulated?

The U.S. Department of Health and Human Services (HHS), the U.S. Food and Drug Administration (FDA) States regulate the use of x-ray equipment. The FDA's Center for Devices and Radiological Health (CDRH) regulates the manufacturing of radiation-emitting electronic equipment.

For pdfFiller’s FAQs

What is FDA 2877?

FDA 2877 is a form used for the reporting of certain information related to biological products and medical devices that are intended for export.

Who is required to file FDA 2877?

Manufacturers, importers, and exporters of biological products and medical devices intended for export are required to file FDA 2877.

How to fill out FDA 2877?

FDA 2877 must be filled out by providing detailed information about the product, including its description, intended use, and specifics about the exporter and the recipient.

What is the purpose of FDA 2877?

The purpose of FDA 2877 is to ensure that the exported biological products and medical devices comply with U.S. regulations and meet safety and efficacy standards.

What information must be reported on FDA 2877?

FDA 2877 requires information such as the product name, description, intended use, the name and address of the manufacturer, exporter, and recipient, as well as any regulatory status related to the product.