Pharmaceutical Regulatory Affairs: Open Access

Siegel SJ

Publications

• Research Article
  FDA Regulation of Medical Devices and Medical Device Reporting
  Author(s): Teow N and Siegel SJTeow N and Siegel SJ
  
  There are three main stakeholders in medical device regulation: people in industry, regulators and practitioners. A medical device report is filed after a device-related adverse event occurs. Studies show that while most medical device reports begin with practitioner observations, people in industry file 97% of reports and practitioners file 3% of reports. The objectives of this article are to identify the major areas of focus in medical device regulation according to industry, regulators, and practitioners, and to investigate the feasibility of increased practitioner participation in medical device rep.. Read More»
  DOI: 10.4172/2167-7689.1000110

  Abstract PDF