The FDA said on Monday that the sudden hike would help the companies to pay the cost of having its products reviewed by the government and also to keep pace with both the rapidly growing medical device industry and changes in technology.
The increase is a part of its recommendations to Congress for reauthorizing the Medical Device User Fee and Modernization Act, which allows the FDA to charge fees for reviewing medical devices seeking federal approval. Unless the Congress reauthorizes the law by September, it will be expired.
The FDA said it needs the fees to allow its device review program to keep pace with both the rapidly growing medical device industry and changes in technology.
According to AP reports, a total of $287 million would be collected in industry fees during the five-year period. It would account for only about 23 percent of the more than $1.2 billion the FDA estimates to spend on reviewing medical devices during that period.
AP quotes Stephen Ubl, president and chief executive officer of AdvaMed, a medical device industry group as saying, "Innovation in the medical technology industry is rapid, and this user fee agreement will provide FDA the resources it needs to prepare for the coming wave of 21st century medical technology."
The FDA also plans to accept public comments on the proposal for the next 30 days, until a scheduled public meeting on April 30.
