A surgeon's perspective regarding the regulatory, compliance, and legal issues involved with physician-modified devices.
review · Level V
Where this comes from
- Record sourced from PubMed, PMID 23446124.
- Also identified by DOI 10.1016/j.jvs.2012.11.043.
- No licence information is recorded for this record.
- Because redistribution is not established, this page shows the abstract only. Follow the links below for the full text.
Abstract
Physician-modified endovascular devices are becoming commonplace in a modern climate where innovation outpaces regulated technological advancement. Off-label use of medical devices occurs on a daily basis throughout many institutions across the United States and when performed by physicians, is both legal and unregulated. The purpose of this invited commentary is to review the regulatory, compliance, and legal issues regarding the practice of medical device modification.
Medical subject headings
- Aortic Aneurysm
- Attitude of Health Personnel
- Blood Vessel Prosthesis
- Blood Vessel Prosthesis Implantation
- Device Approval
- Endovascular Procedures
- Stents
- United States Food and Drug Administration