FDA Releases New User Fee Structure
Manufacturers now know how much more than can expect to pay for 510(k), premarket approval (PMA), and other applications to the U.S. Food and Drug Administration (FDA) under a new user-fee structure that goes into effect Oct. 1.
Starting that date, 510(k) applicants will pay $4,960, roughly $1,500 more than the current fee, and PMA applicants must pay $248,000, a $63,000 increase.
The increases shouldn’t come as a surprise to the industry, which, in negotiations with the agency, had agreed to let the FDA collect $595 million in fees over five years, double the current amount. The FDA in turn will adopt measures to improve device review times.
Congress reauthorized the user-fee program last month as part of the Food and Drug Administration Safety and Innovation Act.
The FDA issued a new guidance document on Aug. 1 that details how some manufacturers can qualify as a small business and pay a lower fee. The guidance document doesn’t contain any major changes from a version issued last year, but does include updated fees for small businesses. Another change is that foreign companies can apply to be a small business even if they have not submitted a federal income tax return.
“Your business may qualify as a small business if you reported ‘gross receipts or sales’ of no more than $100 million for the most recent tax year,” the document reads. “If you have any affiliates, you must add their gross receipts or sales to yours and the total must be no more than $100 million.”
For more information on the user-fee program, click here.
MDUFA III Fees |
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The fees for 2013 are as follows (small-business fees in parentheses): |
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Premarket approval applications: |
$248,000 |
($62,000) |
Panel-track PMA supplements: |
$186,000 |
($46,500) |
180-day supplements: |
$37,200 |
($9,300) |
Real-time supplements: |
$17,360 |
($4,340) |
510(k): |
$4,960 |
($2,480) |
30-day notice: |
$3,968 |
($1,984) |
Request for classification: |
$3,348 |
($1,674) |
PMA annual report: |
$8,680 |
($2,170) |
Annual establishment registration fee: |
$2,575 |
($2,575) |
Posted: August 15, 2012