Food and Drug Administration Guidance Documents and New Medical Devices: The Case of Breast Prostheses

Am J Ther. 2021 Jan-Feb;28(1):e127-e130. doi: 10.1097/MJT.0000000000000888.

Authors

Rachel E Weitzman¹, Ariel D Stern², Daniel B Kramer^{1

3}

Affiliations

¹ Harvard Medical School, Boston, MA.
² Harvard Business School, Boston, MA; and.
³ The Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, MA.

PMID: 33369910
DOI: 10.1097/MJT.0000000000000888

No abstract available

MeSH terms

Device Approval*
Humans
Prostheses and Implants*
United States
United States Food and Drug Administration