Passage of Medical Device User Fee Agreement applauded by MITA
Press releases may be edited for formatting or style | October 03, 2022
Business Affairs
Washington, D.C. – The Medical Imaging & Technology Alliance (MITA) – the leading trade association representing manufacturers of medical imaging equipment, radiopharmaceuticals, contrast media, and focused ultrasound therapeutic devices – today applauded the recent passage of the fifth iteration of the Medical Device User Fee Agreement (MDUFA V) as part of the Continuing Resolution.
"We're excited to now get to work with the FDA and Congress to begin implementing user fee programs that support timely approval and delivery of safe and effective medical innovations," said Patrick Hope, executive director of MITA. "Passage of this agreement is a win for American patients and a promising development in our continued work with policymakers to ensure access to cutting-edge technologies and availability of the best possible care."
MITA helped negotiate the final MDUFA V, which grants the FDA $1.784 billion in User Fees over the next five years, with the potential to raise funding up to $1.9 billion if the agency meets certain performance goals. The final agreement also includes a targeted Total Product Lifecycle Advisor Program (TAP) pilot project to facilitate interaction between FDA and industry on novel innovative products. The TAP pilot program includes a mid-point assessment to allow the FDA and industry to evaluate the program's effectiveness.
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The Medical Imaging & Technology Alliance (MITA), a division of NEMA, is the collective voice of medical imaging equipment manufacturers, innovators, and product developers. It represents companies whose sales comprise more than 90 percent of the global market for advanced medical imaging technology. For more information, visit www.medicalimaging.org. Follow MITA on Twitter @MITAToday.
"We're excited to now get to work with the FDA and Congress to begin implementing user fee programs that support timely approval and delivery of safe and effective medical innovations," said Patrick Hope, executive director of MITA. "Passage of this agreement is a win for American patients and a promising development in our continued work with policymakers to ensure access to cutting-edge technologies and availability of the best possible care."
MITA helped negotiate the final MDUFA V, which grants the FDA $1.784 billion in User Fees over the next five years, with the potential to raise funding up to $1.9 billion if the agency meets certain performance goals. The final agreement also includes a targeted Total Product Lifecycle Advisor Program (TAP) pilot project to facilitate interaction between FDA and industry on novel innovative products. The TAP pilot program includes a mid-point assessment to allow the FDA and industry to evaluate the program's effectiveness.
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The Medical Imaging & Technology Alliance (MITA), a division of NEMA, is the collective voice of medical imaging equipment manufacturers, innovators, and product developers. It represents companies whose sales comprise more than 90 percent of the global market for advanced medical imaging technology. For more information, visit www.medicalimaging.org. Follow MITA on Twitter @MITAToday.
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