FDA Proposes Fee Changes For Medical Device Companies

The FDA is looking to establish predictable fees and improve review times.

The FDA proposed on Monday recommendations to Congress for reauthorizing the Medical Device User Fee and Modernization Act (MDUFMA II).

The next 30 days will be a public comment period and a public meeting will be held on April 30.

Under the user fee program, industry covers some of the costs of FDA’s pre-market review program. The FDA’s annual appropriations are combined with the fees. The industry user fees are less than a quarter of the overall device budget for MDUFMA II.

“The proposal would give companies predictable fees and improved review times as well as provide FDA with a steady source of additional funding for its device review program,” said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. “We look forward to working with Congress on this proposal.”

“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,” said Stephen J. Ubl, president and CEO of medical device industry group AdvaMed. “The agreed-upon performance goals will help keep the pipeline of innovation moving forward and improve communication and understanding between agency staff and manufacturers of medical technology.”

For more information about the proposal, click here

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