Medical device companies will pay about $1 billion in fees to the Food and Drug Administration (FDA) from 2018 to 2022 to give the agency resources to hire additional reviewers and to fund information technology and infrastructure improvements, according to a report in Politico citing statements by three device trade associations.
The fees reflect a 68 percent increase above the $595 million the industry pays under the current agreement, which was agreed to in 2012.
“This tentative agreement is good news for FDA and industry, and most importantly for patients worldwide,” said AdvaMed President & CEO Scott Whitaker in a report published by Mass Device. “This agreement will allow for continued progress in improving the efficiency and predictability of the agency’s review process, and that means doctors and patients will have more timely access to the innovative tests, treatments and cures they are depending on.”
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