Anson Group
October 19, 2007

New FDA User Fees for Medical Device Manufacturers

Effective October 1, FDA revised the Medical Device User Fee Act that enacts some considerable changes including a fee of $1,706 that is now required for all renewals and new medical device establishment registrations.

Registrations and Listings must be entered into the new electronic system by December 31, 2007.

Anson offers the service of completing the new electronic Registration and Device Listings. Contact Allison Scott at ascott@ansongroup.com or 317.569.9500 x106, for more information about this assistance.

New Establishment Registration Fee

For fiscal year 2008 (10/1/07 through 9/30/08) FDA now requires a Medical Device Establishment Registration fee of $1,706 for every renewal and new medical device establishment registration. Contract Manufacturers and Contract Sterilizer companies responsible for commercial distribution are also subject to this fee.

Establishment Registrations, Device Listings and Renewals/Changes Are Electronic

FDA now requires Establishment Registrations, Establishment Registration renewals, Device Listings and Device Listing changes to be performed on the Internet. These were submitted by hard copy in the past. Existing Establishment Registrations should receive an account ID and password/PIN from FDA to complete this process. All existing Establishment Registrations must be renewed electronically prior to Dec. 31, 2007.

New Fees for Specific Submission Types>/b> Additional submission types are now subject to FDA user fees:

  • 30-day Notice ($2,960.00 / Small Business $1,480)
  • Request for Classification Information [513(g) Request] ($2,498 / Small Business $1,249)
  • Class III Annual Report ($6,475.00 / Small Business $1,619)

    • Reduction of Existing Fees

    510(k) Submissions: FDA has reduced the standard and Small Business fees applicable to 510(k) submissions ($3,404.00 / Small Business $1,702.00). Previously the fees were $4,158.00 / $3,326.00.

    PMAs:

  • The new fee for a PMA is $185,000 and $46,250 for a Small Business (previously $281,600 / $107,008).
  • A PMA Supplement fee is now $138,750 and $34,688 for a Small Business (previously $281.600 / $107,008).
  • A BLA Efficacy Supplement fee is now $185,000 and $46,250 for a Small Business (previously $281,600 / $107,008).
  • A 180-day PMA Supplement fee is now $27,750.00 and $6.938.00 for a Small Business (previously $60,544.00 / $23,007.00).
  • A Real-time PMA Supplement fee is now $12,950.00 and $3,237.00 for a Small Business (previously $20,275.00 / $7,705.00).

    • Foreign Establishments Now Eligible for Small Business Certification

    Foreign establishments are now eligible for Small Business certification upon submission of their National Taxing Authority Certification (the equivalent of the U.S. Internal Revenue Service.) A Small Business is defined as having $100 million or less in gross sales and receipts of all affiliates, partners and parent firms. Small firms with gross sales of $30 million or less would be eligible to have the fee on their first PMA waived. Other fee reductions, as described above, apply to Small Business designees, as well.

    The Guidance on how to apply for Small Business Designation is now available: Small Business Qualification Guide (PDF)

    Contact Anson for more information.