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.

  • Correspondence
  • Published:

Early experience with the FDA’s Breakthrough Devices program

Nature Biotechnology volume 38, pages 933–938 (2020)Cite this article

Subjects

To the Editor — The US Congress authorized the Food and Drug Administration (FDA) Breakthrough Devices Program (BDP) in December 2016 in an effort to expedite patient access to innovative devices indicated for the diagnosis and treatment of serious illnesses1. In August 2019, the US Centers for Medicare and Medicaid Services (CMS) subsequently finalized changes increasing hospital reimbursement for breakthrough devices to promote clinical adoption2. Since program inception, the BDP has grown at a rapid and increasing pace: as of 1 January 2020, the FDA had granted breakthrough designation to 222 devices, representing nearly 200% program growth over the past year. To shorten device development and review times, the FDA has approved breakthrough devices on the basis of less rigorous premarket evidence with the intention of collecting complementary postmarket data. For example, the FDA has approved breakthrough devices without supporting effectiveness data (for example, an insulin pump) or with substantial safety risks (for example, pneumothorax rates >30%). Nonetheless, breakthrough devices may be commercially available in Europe for years before FDA approval.

As BDP devices now begin to enter the market, patients, physicians and policymakers should understand key features of the BDP and their implications for clinical decision-making. Herein, we detail early FDA experience with the BDP and offer strategies to guide policy and practice moving forward. To strengthen regulation of breakthrough devices, we argue that the FDA should collaborate with regulatory counterparts — particularly those in the European Union — to exploit real-world postmarket experience. Furthermore, the FDA and CMS should coordinate clinical study requirements for breakthrough devices to facilitate Medicare coverage determinations and support clinical decision-making. Such measures may help ensure that the BDP helps deliver safe and effective devices to patients with unmet clinical needs.

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

Fig. 1: Number of FDA-designated breakthrough devices between 13 December 2016 and 1 January 2020.

References

  1. United States Congress. 21st Century Cures Act https://www.congress.gov/bill/114th-congress/house-bill/34/text.%20 (2016).

  2. Centers for Medicare & Medicaid Services. FY 2020 IPPS/LTCH PPS final rule. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/FY2020-IPPS-Final-Rule-Home-Page (2019).

  3. Rising, J. P. & Moscovitch, B. PLoS One 10, e0117235 (2015).

    Article  Google Scholar 

  4. Makower, J., Meer, A. & Denend, L. FDA impact on U.S. medical technology innovation: a survey of over 200 medical technology companies. https://www.advamed.org/sites/default/files/resource/30_10_11_10_2010_Study_CAgenda_makowerreportfinal.pdf (2010).

  5. Holmes, D. R. Jr. et al. JACC Cardiovasc. Interv. 9, 626–628 (2016).

    Article  Google Scholar 

  6. US Food and Drug Administration. Medical device innovation initiative white paper. https://www.fda.gov/about-fda/cdrh-innovation/medical-device-innovation-initiative-white-paper (2019).

  7. Dhruva, S. S., Bero, L. A. & Redberg, R. F. J. Am. Med. Assoc. 302, 2679–2685 (2009).

    Article  CAS  Google Scholar 

  8. US Food and Drug Administration. Report to Congress: Breakthrough Devices Program. https://www.fda.gov/media/124747/download (2019).

  9. Hwang, T. J., Darrow, J. J. & Kesselheim, A. S. J. Am. Med. Assoc. 318, 2137–2138 (2017).

    Article  Google Scholar 

  10. Kesselheim, A. S. et al. J. Am. Med. Assoc. 315, 1516–1518 (2016).

    Article  Google Scholar 

  11. Krishnamurti, T., Woloshin, S., Schwartz, L. M. & Fischhoff, B. JAMA Intern. Med. 175, 1856–1858 (2015).

    Article  Google Scholar 

  12. Rathi, V. K., Krumholz, H. M., Masoudi, F. A. & Ross, J. S. J. Am. Med. Assoc. 314, 604–612 (2015).

    Article  CAS  Google Scholar 

  13. Agusti, A. & Sin, D. D. Clin. Chest Med. 35, 131–141 (2014).

    Article  Google Scholar 

  14. Kramer, D. B., Xu, S. & Kesselheim, A. S. N. Engl. J. Med. 366, 848–855 (2012).

    Article  CAS  Google Scholar 

  15. Martelli, N. et al. Cardiovasc. Interv. Radiol. 42, 1272–1278 (2019).

    Article  Google Scholar 

  16. Zile, M. R. et al. Am. Heart J. 204, 139–150 (2018).

    Article  Google Scholar 

  17. Shuren, J. & Califf, R. M. J. Am. Med. Assoc. 316, 1153–1154 (2016).

    Article  Google Scholar 

  18. Judson, T. J., Dhruva, S. S. & Redberg, R. F. Br. Med. J. 365, l2190 (2019).

    Article  Google Scholar 

  19. Centers for Medicare & Medicaid Services, US Food and Drug Administration. Program for parallel review of medical devices. Federal Register https://www.federalregister.gov/documents/2016/10/24/2016-25659/program-for-parallel-review-of-medical-devices (2016).

  20. Centers for Medicare & Medicaid Services. Decision memo for next generation sequencing (NGS) for Medicare beneficiaries with advanced cancer (CAG-00450N). https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=290 (2018).

  21. Foster, N. L., Mottola, K. & Hoffman, J. M. JAMA Neurol. 71, 399–400 (2014).

    Article  Google Scholar 

  22. Reynolds, I. S., Rising, J. P., Coukell, A. J., Paulson, K. H. & Redberg, R. F. JAMA Intern. Med. 174, 1773–1779 (2014).

    Article  Google Scholar 

  23. Roginiel, A. C., Dhruva, S. S. & Ross, J. S. Med. (Baltim.) 97, e12715 (2018).

    Article  Google Scholar 

  24. US Food and Drug Administration. Breakthrough Devices Program: guidance for industry and Food and Drug Administration staff. https://www.fda.gov/media/108135/download (2018).

Download references

Author information

Authors and Affiliations

  1. Yale University School of Medicine, New Haven, CT, USA

    James L. Johnston

  2. San Francisco Veterans Affairs Medical Center, San Francisco, CA, USA

    Sanket S. Dhruva

  3. Department of Medicine, University of California, San Francisco School of Medicine, San Francisco, CA, USA

    Sanket S. Dhruva

  4. Center for Outcomes Research and Evaluation (CORE), Yale–New Haven Hospital, New Haven, CT, USA

    Joseph S. Ross

  5. Section of Health Policy and Administration, Department of Epidemiology and Public Health, Yale University School of Medicine, New Haven, CT, USA

    Joseph S. Ross

  6. Section of General Internal Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA

    Joseph S. Ross

  7. Department of Otolaryngology – Head and Neck Surgery, Massachusetts Eye and Ear Infirmary, Boston, MA, USA

    Vinay K. Rathi

Authors
  1. James L. Johnston
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Sanket S. Dhruva
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Joseph S. Ross
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Vinay K. Rathi
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Vinay K. Rathi.

Ethics declarations

Competing interests

In the past 36 months, J.S.R. received research support through Yale University from Medtronic, Inc. and the FDA to develop methods for postmarket surveillance of medical devices (U01FD004585), from the CMS to develop and maintain performance measures that are used for public reporting (HHSM-500-2013-13018I), and from the Blue Cross Blue Shield Association to better understand medical technology evaluation. J.S.R. currently receives research support through Yale University from Johnson & Johnson to develop methods of clinical trial data sharing, from the FDA to establish the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) program (U01FD005938), from the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology (NESTcc), from the Agency for Healthcare Research and Quality (R01HS022882), from the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) (R01HS025164, R01HL144644), and from the Laura and John Arnold Foundation to establish the Good Pharma Scorecard at Bioethics International and to establish the Collaboration for Research Integrity and Transparency (CRIT) at Yale. S.S.D. reports receiving travel support from the FDA and the National Evaluation System for Health Technology (NESTcc). J.L.J. has received support from the FDA through the CERSI program. Research reported in this publication was supported by National Heart, Lung and Blood Institute of the National Institutes of Health. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Heart, Lung, and Blood Institute or the National Institutes of Health under Award Number T35HL007649.

Supplementary information

Supplementary Tables

Tables 1 and 2

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Johnston, J.L., Dhruva, S.S., Ross, J.S. et al. Early experience with the FDA’s Breakthrough Devices program. Nat Biotechnol 38, 933–938 (2020). https://doi.org/10.1038/s41587-020-0636-7

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1038/s41587-020-0636-7

This article is cited by

Search

Advanced search

Quick links

Nature Briefing

Sign up for the Nature Briefing newsletter — what matters in science, free to your inbox daily.

Get the most important science stories of the day, free in your inbox. Sign up for Nature Briefing