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Fda form 3881 download

Fda form 3881 download-2025

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The document is a communication from the FDA to Viet Glove Corporation regarding the approval of their Powder Free Latex Examination Glove with a protein labeling claim. It confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed under general controls provisions of the Federal Food, Drug, and Cosmetic Act. The letter outlines compliance requirements and provides information on labeling and reporting obligations.

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Click ‘Get Form’ to open the FDA Form 3881 in our platform's editor.
Begin by entering the 510(k) number if known, which is essential for tracking your submission.
In the 'Device Name' section, clearly specify the name of your device, ensuring it matches the product label.
Describe the 'Indications for Use' accurately. This should detail the purpose of your device and its intended use in medical settings.
Select the appropriate type of use by checking either 'Prescription Use' or 'Over-The-Counter Use', based on how you intend to market your device.
If additional space is needed, utilize a separate page as indicated in the form instructions.

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Versions	Form popularity	Fillable & printable
2020	4.8 Satisfied (137 Votes)
2014	4.8 Satisfied (60 Votes)

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Who needs an FDA registration?

Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA. Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug products.

Is FDA registration the same as approval?

Companies also register any products they develop in a process known as listing. However, its important to note that FDA registration does not imply any approval or clearance of their products.

What is the FDA form 3881?

Form FDA 3881, or the Indications for Use Statement, should have the same information as the indications for use listed throughout the rest of the 510(k), including device labeling. It should identify whether the device is for prescription and/or over-the-counter use.

What is drug registration?

The purpose of Drug Registration is to ensure that a pharmaceutical product has been adequately tested and evaluated for safety, efficacy and quality, and that the product information provided by the manufacturer is accurate.

How do I submit MedWatch to FDA?

If you need information or if you have questions or comments about a medical product, please call the FDAs toll-free information line, 1-888-INFO-FDA (1-888-463-6332) Press 2 to report into MedWatch or for instructions.

form fda 3881

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What is the FDA drug registration form?

Form FDA 2656 This form is used by all drug firms both domestic and foreign who are required to register and drug list products with the Food and Drug Administration. This form is also used to provide updates in registration information annually or at the discretion of the registrant, when any changes occur.