Life Sciences

MDUFMA changes to user fees and small business qualification

Device Regulation Alert: Safety, Compliance and Reimbursement News, October 8, 2007

Last week President Bush signed the Food and Drug Administration Amendments Act of 2007, which reauthorized the medical device user fee program. That reauthorization brings some changes. On September 28, the FDA summarized some of those changes on its Web site.

The FDA promised more information regarding the changes to the medical device user fee program but in the meantime highlighted the following changes:

  • Application fees substantially reduced
  • New user fee for periodic reporting concerning Class III devices
  • New user fee for 30-day notice submissions under section 515(d)(6) requesting to make manufacturing modifications
  • New user fee for 513(g) requests for device classification information and device requirements
  • New user fee for registration of the following medical device establishments: manufacturers, single-use device reprocessors, and specification developers
  • Medical device establishment mandatory registration and listing via the Internet between October 1 and December 31 annually
      Click here to review the summary.

      On October 2, the FDA released a notice concerning foreign small business qualification certification. That guidance provides a new way for foreign businesses to qualify as a small business.

      Until now, foreign businesses had to submit a US income tax return showing gross receipts and sales no greater than the required threshold ($100 million). That meant businesses that didn't or couldn't file a US tax return couldn't qualify as a small business and didn't get to pay the reduced user fees for small businesses.

      Effective October 1, foreign businesses can submit certification forms from that foreign business's "taxing authority" (the equivalent of the IRS) if it is written in English and provides specified information such as the gross receipts and sales for the most recent year (in local and US currency).

      Click here to read the notice.

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