FDA update May 30 2012

Guidance for Small Business Qualification and Certification FY 2012:

This guidance is substantively the same as the guidance provided for FY 2011. with some changes that we want to bring to your attention.

Important Changes to the FY 2012 Guidance are as follows:

  • Dates cited throughout the guidance to reflect those that apply to the new fiscal year.
  • Information on standard and small business fees to reflect the new fee rates for FY 2012.
  • Added contact information for each foreign National Taxing Authority known to FDA.
  • Updated FDA telephone numbers and addresses throughout the guidance to reflect relocation of some FDA operations.
  • The guidance explains that there is no small business discount for the establishment registration fee. If this is the only fee you expect to pay during FY 2012, you should not submit an FY 2012 Small Business Qualification Certification.
  • A foreign business may qualify as a small business, even if you have not submitted a Federal (U.S.) income tax return.

 

In an effort to reduce the burden on small businesses, FDA provides a new reduced rate for firms that meet the definition of a small business. This guidance explains

  • How your business may qualify as a “small business” and pay most FY 2012 medical device user fees at substantially discounted rates;
  • updated information on standard and small business fees to reflect the new fee rates for FY 2012
  • Updated contact information for each foreign National Taxing Authority
  • Updated FDA telephone numbers and addresses throughout the guidance to reflect relocation of some FDA operations.
  • There is no small business discount for the establishment registration fee.  If this is the only fee you expect to pay during FY 2012, you should not submit an FY 2012 Small Business Qualification Certification.
  • A foreign business may qualify as a small business, even if you have not submitted a Federal (U.S.) income tax return.
  • FDA will review your Small Business Qualification Certification within 60 days of receipt.
  • As of September 30, 2011, this document supersedes “Guidance for Industry, FDA, and Foreign Governments: FY 2011 Medical Device User Fee Small Business Qualification and Certification,” August 3, 2010.

Benefits of qualifying as a Small Business
If you qualify as a small business, you will be able to pay significantly lower user fees than you would otherwise pay: 

You may pay reduced small business fees instead of the standard fees.  If you qualify as a small business, you will be eligible to pay a reduced fee for

  • Each of your medical device submissions that is subject to a user fee;
  • Each of your class III devices that is subject to periodic reporting.

To pay a reduced small business fee, you must qualify as a small business with gross receipts or
Sales of no more than $100 million, including the gross receipts or sales of all of your affiliates.

You may obtain a one-time waiver of the fee for your first (ever) premarket application(Premarket approval application, biologics license application, product development protocol, or premarket report).

To qualify for this fee waiver, you must qualify as a small business with gross receipts or sales of no more than $30 million, including the gross receipts or sales of all of your affiliates

Any questions on this FDA guidance please email us at info@mdiconsultants.com and Ref: Small Business Qualification and Certification FY 201 -  or call us at 516-482-9001 and ask for to speak with one of our FDA regulatory consultants specialists.

For more information on this import alert you can go to the following link: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/UCM267051.pdf?source=govdelivery