Get the free 21 CFR Part 801 -- Labeling

APPLICATION FORMCompany Name: : Full Address: : MD/CEO Name:Program Contact Name: : Telephone::Mobile : Fax:Email:: Standard(s) to which certification sought Please tick which required :

How to fill out 21 cfr part 801

How to fill out 21 cfr part 801

1. Familiarize yourself with the requirements outlined in 21 CFR Part 801.
2. Gather all necessary information and documentation related to the device being regulated.
3. Fill out the required sections of Form FDA 3613 for Initial Registration and Listing or Form FDA 3613a for Annual Registration.
4. Submit the completed forms electronically through the FDA Unified Registration and Listing System (FURLS).
5. Await confirmation of registration and listing from the FDA.

Who needs 21 cfr part 801?

1. Manufacturers, re-packagers, re-labelers, and relabelers of medical devices are required to comply with 21 CFR Part 801.

For pdfFiller’s FAQs

How can I manage my 21 cfr part 801 directly from Gmail?

It's easy to use pdfFiller's Gmail add-on to make and edit your 21 cfr part 801 and any other documents you get right in your email. You can also eSign them. Take a look at the Google Workspace Marketplace and get pdfFiller for Gmail. Get rid of the time-consuming steps and easily manage your documents and eSignatures with the help of an app.

Can I create an electronic signature for the 21 cfr part 801 in Chrome?

Yes. By adding the solution to your Chrome browser, you can use pdfFiller to eSign documents and enjoy all of the features of the PDF editor in one place. Use the extension to create a legally-binding eSignature by drawing it, typing it, or uploading a picture of your handwritten signature. Whatever you choose, you will be able to eSign your 21 cfr part 801 in seconds.

How can I fill out 21 cfr part 801 on an iOS device?

Download and install the pdfFiller iOS app. Then, launch the app and log in or create an account to have access to all of the editing tools of the solution. Upload your 21 cfr part 801 from your device or cloud storage to open it, or input the document URL. After filling out all of the essential areas in the document and eSigning it (if necessary), you may save it or share it with others.

What is 21 cfr part 801?

21 CFR Part 801 pertains to labeling requirements for medical devices and provides regulations on the information that must accompany devices to ensure safe and effective use.

Who is required to file 21 cfr part 801?

Manufacturers, importers, and distributors of medical devices are required to adhere to the regulations outlined in 21 CFR Part 801 for the labeling of their products.

How to fill out 21 cfr part 801?

To comply with 21 CFR Part 801, manufacturers must ensure that their labeling includes all necessary information as specified by the FDA, such as device description, intended use, instructions, warnings, and other required statements. Detailed guidance can be found in the FDA's official documentation.

What is the purpose of 21 cfr part 801?

The purpose of 21 CFR Part 801 is to ensure that medical device labeling is truthful, not misleading, and provides sufficient information for users to make informed decisions about the safe and effective use of the devices.

What information must be reported on 21 cfr part 801?

Information required includes the device name, intended use, directions for use, warnings, and any contraindications, among other specific labeling requirements established by the FDA.