Get the free FDA 2877

The Form FDA 2877 must be completed for electronic products subject to Radiation Control Standards prior to entry into the United States. It provides declarations related to the compliance status

How to fill out fda 2877

How to fill out FDA 2877

1. Obtain the FDA Form 2877 from the FDA website or authorized source.
2. Fill in the header information including the submitter's name, address, and contact information.
3. Provide the product name and description in the appropriate fields.
4. Indicate the type of submission (e.g., new, modified, or other) in the designated section.
5. Include any relevant details about the product such as ingredients and intended use.
6. If applicable, provide information about any previous submissions or approvals related to the product.
7. Review all entries for accuracy and completeness.
8. Sign and date the form where indicated.
9. Submit the completed form according to the instructions provided, either electronically or via mail.

Who needs FDA 2877?

1. Individuals or companies planning to introduce, market, or distribute a product that requires FDA approval.
2. Manufacturers of food, drugs, biologics, or medical devices that are subject to FDA regulations.
3. Importers of products that require FDA compliance.

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 reporting the importation of certain medical devices into the United States.

Who is required to file FDA 2877?

Any entity that imports certain medical devices into the United States is required to file FDA 2877.

How to fill out FDA 2877?

To fill out FDA 2877, provide the required information about the importer, the product, and the shipment details as specified in the instructions accompanying the form.

What is the purpose of FDA 2877?

The purpose of FDA 2877 is to collect information about imported medical devices to ensure they meet safety and efficacy standards.

What information must be reported on FDA 2877?

FDA 2877 requires reporting information such as the name and address of the importer, the product details, and the shipment information.