Connie Hoy joined Xoft, Inc as VP RA / QA in December, 2007. Prior to that she spent over 12 years working in the medical laser industry, most recently as VP RA/ QA at Cutera, Inc and prior to that VP RA / QA at Lumenis, Inc.
Connie began her career 22 years ago at a start-up company that developed sterile implantable devices. During her 8 years at Oco Biomedical, she served as the President of the Dental Implant Manufacturer’s Association and the Southwest Biomedical Coalition. In 1995 she joined Tissue Technologies as the Director of Regulatory Affairs, where she led the effort to become one of the first ISO 9001 / EN 46001 certified medical companies in the US. When Tissue Technologies was acquired by Palomar Medical, Connie served as a transition team member and subsequently worked for Palomar as the team leader for ISO implementation at the Palomar home office and for their subsidiaries located in Auburn, CA and Pleasanton, CA. Connie was also an industry representative on the advisory board that consulted with FDA on the implementation of the 1996 revision of the Quality System Regulations.
Connie then joined Cell Robotic, Inc where she obtained the first 510(K) clearance for a medical laser device to be sold into the home. The device was used for obtaining capillary blood samples for diabetes testing. This led to a move from Albuquerque NM to Woodland CA where she continued her career in the laser industry.
This presentation will review the various actions that may be taken by a medical device manufacturer when it is determined that there is a health risk to the public that requires action. One challenge is how to decide when a recall or correction / removal is warranted. We will review some specific case studies that reflect the FDA perspective on this. Once the decision for a recall is made, specific documentation must be generated and timelines must be met. We will then discuss what these actions are as well as how to interface with the FDA and what can be expected by the FDA.
The relationship between incidents in the US and outside the US will then be covered to add clarity on what is appropriate.
Finally, Connie will discuss how to minimize the impact of a recall on your business.
