A surgeon’s perspective regarding the regulatory, compliance, and legal issues involved with physician-modified devices

Author:

Starnes Benjamin W.

Publisher

Elsevier BV

Subject

Cardiology and Cardiovascular Medicine,Surgery

Reference5 articles.

1. Clinical experience with a customized fenestrated endograft for juxtarenal abdominal aortic aneurysm repair;Uflacker;J Vasc Interv Radiol,2006

2. Physician-modified endovascular grafts for the treatment of elective, symptomatic, or ruptured juxtarenal aortic aneurysms;Starnes;J Vasc Surg,2012

3. “Food and Drug Administration Modernization Act of 1997.” The National Academies. Available at: http://www7.nationalacademies.org/ocga/laws/PL105_115.asp. Accessed August 18, 2012.

4. Gee T. Impact of Modifying FDA Regulated Devices, October 25, 2009. Available at: http://medicalconnectivity.com/2009/10/25/impact-of-modifying-fda-regulated-devices.

5. Legal implications of pushing the endovascular envelope;Brown;J Vasc Surg,2012

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