Modeling and Simulation in Biomedical Engineering: Regulatory Science and Innovation for Advancing Public Health

Tina M Morrison¹, Joel D Stitzel^{2

3

4}, Steve M Levine^{2

3

4}

Affiliations

¹ Office of Regulatory Science and Innovation, US Food and Drug Association, Silver Spring, MD, USA. Tina.Morrison@fda.hhs.gov.
² Office of Regulatory Science and Innovation, US Food and Drug Association, Silver Spring, MD, USA.
³ Wake Forest University School of Medicine, Winston-Salem, NC, USA.
⁴ Dassault Systèmes, San Diego, CA, USA.

Editorial

Tina M Morrison et al. Ann Biomed Eng. 2023 Jan.

. 2023 Jan;51(1):1-5.

doi: 10.1007/s10439-022-03116-7. Epub 2022 Dec 23.

Tina M Morrison¹, Joel D Stitzel^{2

3

4}, Steve M Levine^{2

3

4}

¹ Office of Regulatory Science and Innovation, US Food and Drug Association, Silver Spring, MD, USA. Tina.Morrison@fda.hhs.gov.
² Office of Regulatory Science and Innovation, US Food and Drug Association, Silver Spring, MD, USA.
³ Wake Forest University School of Medicine, Winston-Salem, NC, USA.
⁴ Dassault Systèmes, San Diego, CA, USA.

No abstract available

References

1. American Society of Mechanical Engineers, Standards Development Organization. Assessing Credibility of Computational Modeling through Verification and Validation: Application to Medical Devices. New York: ASME, 2018
1. Center for Devices and Radiological Health. Draft Guidance for Industry and Food and Drug Administration Staff, Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions. Center for Devices and Radiological Health. Retrieved November 22, 2022, from https://www.fda.gov/regulatory-information/search-fda-guidance-documents... .
1. Center for Devices and Radiological Health. Guidance for Industry and Food and Drug Administration Staff. Center for Devices and Radiological Health. Retrieved November 22, 2022, from https://www.fda.gov/regulatory-information/search-fda-guidance-documents... .
1. Cohen, J. FDA Commissioner Califf Says Business of Health is Booming in U.S. But Patients’ Outcomes Aren’t Improving. Retrieved November 22, 2022, from https://www.forbes.com/sites/joshuacohen/2022/05/04/fda-commissioner-cal... .
1. Cowey, C. L., et al. Real-world treatment outcomes in patients with metastatic Merkel cell carcinoma treated with chemotherapy in the USA. Future Oncol. 13(19):1699–1710, 2017 - DOI