Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Apr 20;6(1):38.
doi: 10.1186/s41687-022-00444-z.

Inclusion of patient-reported outcome instruments in US FDA medical device marketing authorizations

Sophia T Matts  1 , Christina M Webber  2 , Fraser D Bocell  2 , Brittany Caldwell  2 , Allen L Chen  2 , Michelle E Tarver  3
Affiliations

Inclusion of patient-reported outcome instruments in US FDA medical device marketing authorizations

Sophia T Matts et al. J Patient Rep Outcomes. .

Abstract

Background: The U.S. Food and Drug Administration encourages the incorporation of the patient voice throughout the medical device total product lifecycle. This study examined the incorporation of patient-reported outcome (PRO) instruments in the evaluation of medical devices over a six-year period. PRO instruments used to inform study endpoints were extracted from the summary documents and clinical trial data of premarket authorizations posted on publicly available FDA databases between October 1, 2014-September 30, 2020.

Results: PROs were included in 53% of authorizations, with 34% using PROs as primary and secondary endpoints. This study found that PRO instruments were used in each type of marketing authorization and in all medical specialties examined in this study.

Conclusions: Expanding the current collaborative efforts to develop and modify PRO instruments may help to improve use of PROs in medical device evaluations.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
PRO inclusion in summary documents fiscal year 2015- fiscal year 2020. The 510(k) cohort consisted of cleared 510(k)s that included clinical trial data. The majority of De Novos granted in fiscal year 2020 did not have summary documents posted within the study window leading to the low n observed. There were no HDE approvals publicly posted in fiscal year 2020. FY = Fiscal year
Fig. 2
Fig. 2
Inclusion of PRO in summary documents, separated by endpoint positioning. Summary documents were grouped by device authorization pathway (premarket approval (PMA), premarket notification [510(k)], Device Classification Under Sect. 510(f) [2] (De Novo), Humanitarian Device Exemption (HDE)). Percentage of marketing authorizations that included a PRO in the summary documents (total bar), separated by the marketing authorizations that used at least one PRO as a primary or secondary endpoint (orange) and those that included PROs as supporting data, either to support ancillary endpoints or without specifying endpoint positioning (blue)
See this image and copyright information in PMC

References

    1. U.S. Food and Drug Administration (2009) Guidance for industry - patient-reported outcome measures: Use in medical product development to support labeling claims. https://www.fda.gov/regulatory-information/search-fda-guidance-documents.... Accessed 3 Nov 2020. - PMC - PubMed
    1. U.S. Food and Drug Administration (2016) Value and use of patient-reported outcomes (PROs) in assessing effects of medical devices. https://www.fda.gov/media/109626/download. Accessed 3 Nov 2020.
    1. U.S. Food and Drug Administration (2020) 21st Century Cures Act. In: Selected amendments to the FD&C Act. Available via https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/2.... Accessed 3 Nov 2020.
    1. U.S. Food and Drug Administration (2016) MDUFA performance goals and procedures, fiscal Years 2018 through 2022. https://www.fda.gov/media/102699/download. Accessed 2 Nov 2020.
    1. U.S. Food and Drug Administration (2020) Medical Device Development Tools (MDDT). In: Science and Research (Medical Devices). Available via https://www.fda.gov/medical-devices/science-and-research-medical-devices.... Accessed 2 Nov 2020.

LinkOut - more resources