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.

  • Patents
  • Published:

PATENTS

The FDA De Novo medical device pathway, patents and anticompetition

Nature Biotechnology volume 38, pages 1028–1029 (2020)Cite this article

Subjects

The interaction between patents and FDA’s De Novo and 510(k) regulatory pathways has the potential to threaten follow-on innovation for medical devices.

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

Relevant articles

Open Access articles citing this article.

Access options

Buy this article

  • Purchase on SpringerLink
  • Instant access to the full article PDF.

USD 39.95

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

References

  1. 21st Century Cures Act. Public Law No 114-255 (2016).

  2. FDA. Guidance for industry and FDA staff: class II special controls guidance document: tissue adhesive for the topical approximation of skin. https://www.fda.gov/media/71148/download (2008).

  3. FDA. Acceptance review for de novo classification requests: guidance for industry and Food and Drug Administration staff. https://www.fda.gov/media/116945/download (2019).

  4. 21 U.S.C.A. § 360c(i)(1).

  5. FDA. FY 2018 Performance report to Congress for the Medical Device User Fee Amendments. https://www.fda.gov/media/130598/download (2019).

  6. FDA. The 510(k) program: evaluating substantial equivalence in premarket notifications. https://www.fda.gov/media/82395/download (2014).

  7. Kelm, K. B. Letter from Kellie B. Kelm, Acting Director, Division of Chemistry and Toxicology Devices, FDA, to Michael Sarrasin, Senior Director of Regulatory and Clinical Affairs, Tandem Diabetes Care, Inc. https://www.accessdata.fda.gov/cdrh_docs/pdf18/DEN180058.pdf (3 December 2019).

  8. Kruse, G. US Patent 10,492,141 (2019).

  9. FDA. De Novo classification request for Bose® Hearing Aid: decision summary. https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN180026.pdf (2018).

  10. Energy Transp. Group, Inc. v. William Demant Holding A/S, 697 F.3d 1342 (Fed. Cir. 2012).

  11. Hearing Components, Inc. v. Shure Inc., 600 F.3d 1357 (Fed. Cir. 2010).

  12. Manchester v. Sivantos GmbH, Case No. 2:17-CV-05309 (C.D. Cal. 2 August 2019).

  13. FDA. De Novo classification request for Monarch eTNS System: decision summary. https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN180041.pdf (2019).

  14. Minssen, T., Gerke, S., Aboy, M., Price, N. & Cohen, G. J. Law Biosci. https://doi.org/10.1093/jlb/lsaa002 (2020).

  15. PwC. 2018 patent litigation study. https://www.pwc.com/us/en/forensic-services/publications/assets/2018-pwc-patent-litigation-study.pdf (2018).

  16. FDA. Evaluation of automatic class III designation for ZIKV Detect 2.0 IgM Capture ELISA: decision summary. https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN180069.pdf (2019).

  17. Evaluation of automatic class III designation for OraQuick Ebola Rapid Antigen Test: decision summary. https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN190025.pdf (2019).

  18. Gutman, S. I. Letter from Steven I. Gutman, Director, Office of In Vitro Diagnostic Device Evaluation and Safety, FDA, to Kate Wersin, Regulatory Affairs Officer, PANBIO Limited. https://www.accessdata.fda.gov/cdrh_docs/pdf3/K031703.pdf (8 July 2003).

  19. Rathi, V. K. & Ross, J. S. N. Engl. J. Med. 381, 1891–1893 (2019).

    Article  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. College of Law, University of Illinois at Urbana-Champaign, Champaign, IL, USA

    Jacob S. Sherkow

  2. Carl R. Woese Institute for Genomic Biology, University of Illinois at Urbana-Champaign, Champaign, IL, USA

    Jacob S. Sherkow

  3. Center for Advanced Studies in Biomedical Innovation Law, University of Copenhagen Faculty of Law, Copenhagen, Denmark

    Jacob S. Sherkow

  4. Centre for Law Medicine and Life Sciences, University of Cambridge, Cambridge, UK

    Mateo Aboy

  5. Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School, Cambridge, MA, USA

    Mateo Aboy

Authors
  1. Jacob S. Sherkow
    View author publications

    Search author on:PubMed Google Scholar

  2. Mateo Aboy
    View author publications

    Search author on:PubMed Google Scholar

Corresponding authors

Correspondence to Jacob S. Sherkow or Mateo Aboy.

Ethics declarations

Competing interests

M.A. serves on the board of APDM Wearable Technologies (APDM, Inc).

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Sherkow, J.S., Aboy, M. The FDA De Novo medical device pathway, patents and anticompetition. Nat Biotechnol 38, 1028–1029 (2020). https://doi.org/10.1038/s41587-020-0653-6

Download citation

  • Published:

  • Version of record:

  • Issue date:

  • DOI: https://doi.org/10.1038/s41587-020-0653-6

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