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

被引：1

作者：

Weitzman, Rachel E. ^{[1
]}

Stern, Ariel D. ^{[2
]}

Kramer, Daniel B. ^{[1
,3
]}

机构：

[1] Harvard Med Sch, Boston, MA 02115 USA

[2] Harvard Sch Business, Boston, MA USA

[3] Beth Israel Deaconess Med Ctr, Richard A & Susan F Smith Ctr Outcomes Res Cardio, Boston, MA 02215 USA

来源：

关键词：

D O I：

10.1097/MJT.0000000000000888

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

引用

页码：E127 / E130

页数：4

共 10 条

[1] AdvaMed, 2016, COMM FDA 2016
[2] [Anonymous], PLAST SURG STAT REP
[3] [Anonymous], GUID DOC MED DEV RAD
[4] The Regulatory Accountability Act of 2017-Implications for FDA Regulation and Public Health
Darrow, Jonathan J.
Brown, Erin C. Fuse
Kesselheim, Aaron S.
[J]. NEW ENGLAND JOURNAL OF MEDICINE, 2018, 378 (05) : 412 - 414
[5] Grand View Research, BREAST IMPLANTS MARK
[6] Patient Satisfaction and Health-Related Quality of Life following Breast Reconstruction: Patient-Reported Outcomes among Saline and Silicone Implant Recipients
Macadam, Sheina A.
Ho, Adelyn L.
Cook, E. F., Jr.
Lennox, Peter A.
Pusic, Andrea L.
[J]. PLASTIC AND RECONSTRUCTIVE SURGERY, 2010, 125 (03) : 761 - 771
[7] U.S. Food and Drug Administration, Premarket Approval (PMA) Database
[8] US FDA, 2004, FDA BREAST IMPL CONS
[9] US Food and Drug Administration, MED DEV PREM PROGR O
[10] US Food and Drug Administration, SEARCH DAT FDA GUID