Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • Comment
  • Published:

Regulatory approaches to stimulate innovative renal replacement therapies

Nature Reviews Nephrology volume 16, pages 546–547 (2020)Cite this article

Subjects

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.

This is a preview of subscription content, access via your institution

Access options

Buy this article

  • Purchase on Springer Link
  • Instant access to full article PDF
Buy now

Prices may be subject to local taxes which are calculated during checkout

References

  1. Luyckx, V. A., Tonelli, M. & Stanifer, J. W. Bull. World Health Organ. 96, 414–422 (2018).

    Article  Google Scholar 

  2. Nexight Group. Kidney Health Initiative https://www.asn-online.org/membership/BlastEmails/files/KHI_RRT_Roadmap1.0_FINAL_102318_web.pdf (2018).

  3. Global Medical Technology Alliance. GMTA http://www.globalmedicaltechnologyalliance.org/papers/GMTA%20Global%20Harmonization%20of%20Medical%20Technology%20Regulations.pdf (2018).

  4. World Health Organization. WHO Global Model Regulatory Framework for medical devices including in vitro diagnostic medical devices (WHO, 2017).

  5. IMDRF MDSAP Working Group. IMDRF http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-151002-mdra-audit-report.pdf (2015).

  6. Kristensen, F. B. et al. Value Health 22, 13–20 (2019).

    Article  Google Scholar 

  7. Wieringa, F. P. & Sheldon, M. Artificial Organs 44, 111–122 (2020).

    Article  Google Scholar 

  8. Benz, H. L. et al. Patient 12, 553–557 (2019).

    Article  Google Scholar 

  9. Mavris, M., Furia Helms, A. & Bere, N. Nat. Rev. Drug Discov. 18, 885–886 (2019).

    Article  CAS  Google Scholar 

Download references

Acknowledgements

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.

Author information

Authors and Affiliations

  1. Foundation imec Netherlands, Connected Health Solutions, Eindhoven, Netherlands

    Fokko P. Wieringa

  2. Maastricht University, Faculty of Health, Medicine and Life Sciences, Maastricht, Netherlands

    Fokko P. Wieringa

  3. Dutch Kidney Foundation, Bussum, Netherlands

    Fokko P. Wieringa

  4. Food and Drug Administration Center for Devices and Radiological Health (FDA-CDRH), Silver Spring, MD, USA

    Murray I. Sheldon

  5. European Medicines Agency (EMA), Amsterdam, Netherlands

    Ana Hidalgo-Simon

Authors
  1. Fokko P. Wieringa
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Murray I. Sheldon
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Ana Hidalgo-Simon
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding authors

Correspondence to Fokko P. Wieringa, Murray I. Sheldon or Ana Hidalgo-Simon.

Ethics declarations

Competing interests

The authors declare no competing interests.

Additional information

Related links

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/

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

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

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1038/s41581-020-0275-8

This article is cited by

Search

Advanced search

Quick links

Nature Briefing: Translational Research

Sign up for the Nature Briefing: Translational Research newsletter — top stories in biotechnology, drug discovery and pharma.

Get what matters in translational research, free to your inbox weekly. Sign up for Nature Briefing: Translational Research