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Do not sell regulatory science short

Nature Medicine volume 27, pages 573–574 (2021)Cite this article

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To the Editor—A recent federal notice1 proposes to permanently remove oversight by the US Food and Drug Administration (FDA) over 91 medical devices, including several devices that apply artificial intelligence and those under temporary COVID-19 waiver. Public needs during a response to an unprecedented public-health emergency aside, the federal notice sends an alarming message—that regulatory science and applying its principles during regulatory review are unnecessary.

The evidence for removal is the lack of adverse events reported in an FDA database2. Assuming that all relevant adverse events are accurately identified in the ‘real world’, and further assuming that all of those adverse events are accurately reported in the FDA database, then the absence of adverse events would indicate that the screened devices are safe and are of ‘low risk’. However, even with those arguably unproven assumptions, the cause for the absence of adverse events has many attributable factors, including the FDA review process itself, which is now subject to removal —simply put, the safety of the current devices driving the removal might be in part attributable to those devices having undergone independent, scientifically sound FDA review. The proposed permanent changes thereby represent a manifestation of the principle that ’nobody ever gets credit for fixing problems that never happened’3; however, it is exactly in this context that regulatory science, with its diverse tools, standards and approaches, is necessary to ensure safety, efficacy, quality and performance to help prevent adverse events4.

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References

  1. Food and Drug Administration. Federal Register https://www.federalregister.gov/documents/2021/01/15/2021-00787/making-permanent-regulatory-flexibilities-provided-during-the-covid-19-public-health-emergency-by (2021).

  2. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm (accessed 21 February 2021).

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  5. Food and Drug Administration. Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science (FARS). https://www.fda.gov/science-research/science-and-research-special-topics/advancing-regulatory-science (2021).

  6. Food and Drug Administration. Collaborative Communities: Addressing Health Care Challenges Together. https://www.fda.gov/about-fda/cdrh-strategic-priorities-and-updates/collaborative-communities-addressing-health-care-challenges-together (accessed February 2021).

  7. Poste, G. The Alliance for Digital Pathology https://digitalpathologyalliance.org/jan-2021-webinar-with-george-poste (2021).

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Author information

Authors and Affiliations

  1. Department of Pathology, Center for Integrated Diagnostics, Massachusetts General Hospital–Harvard Medical School, Boston, MA, USA

    Jochen K. Lennerz & Hetal D. Marble

  2. Friends of Cancer Research, Washington, DC, USA

    Laura Lasiter

  3. School of Life Sciences, Complex Adaptive Systems and Health Innovation, Arizona State University, Scottsdale, AZ, USA

    George Poste

  4. Pathology Informatics, Memorial Sloan Kettering Cancer Center, New York, NY, USA

    S. Joseph Sirintrapun

  5. Department of Pathology, GZA-ZNA Hospitals, Antwerp, Belgium

    Roberto Salgado

  6. Peter Mac Callum Cancer Centre, Division of Research, Melbourne, Victoria, Australia

    Roberto Salgado

Authors
  1. Jochen K. Lennerz
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  2. Hetal D. Marble
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  3. Laura Lasiter
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  4. George Poste
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  5. S. Joseph Sirintrapun
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  6. Roberto Salgado
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Contributions

J.K.L. and R.S. generated the concept; J.K.L. wrote the initial draft; H.D.M., L.L. and S.J.S. edited the manuscript; G.P. and R.S. commented on the draft; and all authors approved the final version.

Corresponding author

Correspondence to Jochen K. Lennerz.

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Competing interests

G.P. reports an advisory role at Exelixis and Caris Life Sciences. R.S. reports non-financial support from Merck and Bristol Myers Squibb; research support from Merck, Puma Biotechnology and Roche; advisory-board fees for Bristol Myers Squibb; and personal fees from Roche for an advisory board related to a trial-research project.

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Lennerz, J.K., Marble, H.D., Lasiter, L. et al. Do not sell regulatory science short. Nat Med 27, 573–574 (2021). https://doi.org/10.1038/s41591-021-01298-6

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