Regulations for market access and reimbursement of medical devices vary across jurisdictions, complicating the development of innovative technologies for world-wide use; however, several converging regulatory principles are now emerging. Here we discuss approaches by which regulatory and related agencies can promote innovation and boost the effectiveness of regulatory processes to expedite patient access to innovative technologies, including renal replacement therapies.
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The authors thank the Regulatory Affairs Professionals Society (RAPS) members A. Saaman (DebioTech), A. Purde (TÜV-SÜD) and K. Trautman (NSF International), as well as International Professional Society for Health Economics and Outcomes Research (ISPOR) members B. Gingles (Cook Medical) and T. Tesoro (ISPOR) for reviewing and providing input into this article. The views expressed in this article are the personal views of the author(s) and may not be understood or quoted as being made on behalf of or reflecting the position of the regulatory agency/agencies or organizations with which the author(s) is/are employed/affiliated.
The authors declare no competing interests.
International Medical Device Regulators Forum (IMDRF): http://www.imdrf.org/
International Professional Society for Health Economics and Outcomes Research (ISPOR): https://www.ispor.org/
Kidney Health Initiative: https://khi.asn-online.org/
Regulatory Affairs Professionals Society (RAPS): https://www.raps.org/
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Wieringa, F.P., Sheldon, M.I. & Hidalgo-Simon, A. Regulatory approaches to stimulate innovative renal replacement therapies. Nat Rev Nephrol 16, 546–547 (2020). https://doi.org/10.1038/s41581-020-0275-8
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