FDA Form 3881-2026

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4.8 out of 5

137 votes

The document is a form from the Department of Health and Human Services, specifically the Food and Drug Administration (FDA), related to the collection of information for medical devices. It includes sections for device name, indications for use, and type of use (prescription or over-the-counter). It also outlines the estimated burden time for completing the form and provides contact information for comments regarding the information collection.

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Click ‘Get Form’ to open it in the editor.
Begin by entering the 510(k) Number if known. This helps identify your submission.
Next, input the Device Name in the designated field to specify what device you are referring to.
In the 'Indications for Use' section, provide a detailed description of how the device is intended to be used.
Select the appropriate Type of Use by checking either 'Prescription Use' or 'Over-The-Counter Use', or both if applicable.
If additional space is needed, continue on a separate page as indicated in the 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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