The Food & Drug Administration is proposing to raise the user fees it charges medical device makers seeking to have their devices approved for market.
The FDA’s 513(g) request for classification process allows device makers to ask the federal watchdog agency how their devices should be classified and what protocol they should use to seek clearance or approval. The agency sets two tiers, one for businesses with more than $100 million in sales and another, lower fee rate for smaller businesses.
The fee for fiscal year 2010 is $2,941 for large businesses; the agency is proposing to raise that by 8.5 percent to $3,191 for fiscal year 2011, which begins in October. The small business fee, currently $1,470, is slated to rise to $1,595 during FY2010, an 8.5 percent increase.
It’s not the only user fee hike the agency plans to implement. The user fee for standard premarket approval applications, which was $217,787 for large businesses this year, is set at $236,298 for FY2011, up 8.5 percent. For small businesses, the agency now charges $54,447 for PMA applications, which is slated to rise to $59,075 next year (for businesses making less that $30 million a year the fee is waived, as it is for first-time applications).
The standard 510(k) user fee for large businesses is $4,348 for the upcoming fiscal year, also an 8.5 percent increase over the $4,007 the agency is currently charging. For small businesses the fee is slated to rise 8.5 percent to $2,174, up from $2,004 this year.