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  • Hhs Fda Form 3881 2020

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How to fill out the HHS FDA Form 3881 online

The HHS FDA Form 3881 is a crucial document for various uses in the health and food regulatory landscape. This guide will provide you with the step-by-step instructions needed to complete the form effectively and efficiently online.

Follow the steps to fill out the HHS FDA Form 3881 online seamlessly.

  1. Click ‘Get Form’ button to obtain the form and access it in the online editor.
  2. Fill in the 510(k) number, if known. This number is essential for identifying specific submissions related to medical devices.
  3. Enter the device name. Be sure to provide the exact name as recognized in the industry to avoid any confusion.
  4. In the 'Indications for Use' section, provide a detailed description of the intended purpose of the device, including how it is supposed to function.
  5. Select the type of use applicable for the device by choosing one or both of the following options: 'Prescription Use' or 'Over-The-Counter Use'. Make sure to follow the relevant regulations pertaining to your choice.
  6. If additional space is needed for 'Indications for Use', continue on a separate page ensuring any additional pages are clearly labeled.
  7. Once all fields are completed and reviewed, proceed to save your changes. You can also choose to download, print, or share the form depending on your needs.

Complete your HHS FDA Form 3881 online today for a smoother regulatory process.

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The FDA has established several programs to help manufacturers demonstrate with reasonable certainty that a chemical is not harmful when used as proposed. These include: Food additives and color additives: Food additives and color additives require pre-market review and approval by the FDA.

Most direct additives are identified on the ingredient label of foods. Under the Federal Food, Drug, and Cosmetic Act, a food additive must be authorized by the FDA before it can be used in food on the market.

FDA Approval is Required by Law Federal law requires all new drugs in the U.S. be shown to be safe and effective for their intended use prior to marketing. However, some drugs are available in the U.S. even though they have never received the required FDA approval.

To apply to market a new drug, biologic, or an antibiotic drug for human use, you need to complete Form 356h. Form 356h includes information such as applicant information, proposed indication, establishment information, and more.

To obtain an FEI number for a GDUFA-related facility, email FDAGDUFAFEIRequest@fda.hhs.gov. To obtain an FEI number for a PDUFA- or BsUFA-related facility, email PDUFABSUFAFEIRequest@fda.hhs.gov. Note: An FEI number is a facility specific identifier.

The Food and Drug Administration (FDA) is an HHS agency that regulates clinical investigations of products under its jurisdiction, such as drugs, biological products, and medical devices.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232
Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
Privacy Notice
Legal Hub
Content Takedown Policy
Bug Bounty Program
About Us
Blog
Affiliates
Contact Us
Delete My Account
Site Map
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate WorkFlow
DocHub
Instapage
Social Media
Call us now toll free:
+1 833 426 79 33
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232