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  • Fda Guidance - 2008 Medical Device User Fee Small

Get Fda Guidance - 2008 Medical Device User Fee Small

Ance for Industry and FDA: FY 2007 MDUFMA Small Business Qualification Worksheet and Certification, August 1, 2006. OMB control number 0910-0613 Expiration date April 16, 2008 See additional PRA statement at the end of this guidance. For questions regarding this document contact Joseph V. Puleo. Phone: (240) 276-3150, extension 116; e-mail: joseph.puleo fda.hhs.gov. U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research Center.

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How to use or fill out the FDA Guidance - 2008 Medical Device User Fee Small online

This guide offers clear and comprehensive instructions for filling out the FDA Guidance - 2008 Medical Device User Fee Small Business Qualification Certification online. By following these steps, users can easily navigate the process to potentially qualify for reduced user fees.

Follow the steps to successfully complete your application.

  1. Press the ‘Get Form’ button to acquire the form and access it in an electronic format.
  2. Begin by filling out Section I, which requests information about your business. Ensure you accurately enter the full legal name of your business as registered.
  3. In Section II, list any affiliates of your business if applicable. For affiliates, provide their names, Taxpayer ID Numbers, and gross receipts or sales.
  4. Review your entries carefully before signing and dating the certification statement at the end of the form to validate that all information is complete and accurate.
  5. Once completed, save your changes, download a copy for your records, and print the form to submit it by mail to the FDA. Ensure to include all necessary supporting documentation, like tax returns.

Complete your FDA Medical Device User Fee Small Business Qualification Certification form online today to ensure you receive the benefits available to small businesses.

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The primary objectives of the SMDA are to accelerate the reporting of adverse events to the FDA, ensure that only safe and effective medical devices are on the market, and rapidly remove defective products from the marketplace.

The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect user fees from persons that submit certain human drug applications for review or that are named in approved applications as the sponsor of certain prescription drug products.

The Medical Device User Fee and Modernization Act of 2002 (MDUFMA), P.L 107-250, amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) to provide FDA new responsibilities, resources, and challenges. MDUFMA was signed into law October 26, 2002.

In 1992, the Prescription Drug User Fee Act (PDUFA) was first enacted, authorizing FDA to assess and collect fees from manufacturers. Since then, a portion of FDA's budget for the review of drugs and biologics has come from industry user fees.

The Medical Device User Fee and Modernization Act (MDUFA) authorizes the Center for Devices and Radiological Health (CDRH) to collect user fees from medical device manufacturers. It is reauthorized every 5 years.

There are two rates for the device review; $5,440 for any small business that sold less than $100 million in the last tax year, and $21,760 for any business that sells more than $100 million in the last tax year.

To support its public health activities, the FDA relies on (1) annual funding that Congress provides for the agency, and (2) Congressionally-authorized user fees paid by industries that make and market FDA-regulated products, and paid by certain other entities.

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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