This exchanged information can be used in a variety of ways including display, store, interpret, analyze, and automatically act on or control another product. Interoperable devices with the ability to share information across systems and platforms can: Improve patient care, Reduce errors and adverse events, and Encourage innovation.
I am pleased to be here today to provide information on the Year 2000 date issue as it relates to medical devices. FDA has taken a number of constructive actions to work with manufacturers and provide information to users about medical device Year 2000 compliance.
Scientific evidence from clinical trials must be provided by the manufacturers demonstrating the safety and effectiveness of their product. Over-the-counter drugs are monitored by the FDA, but they are submitted to a less rigorous testing procedure, especially if they are assumed to be safe.
Cardiac medicine is just one of many therapeutic areas virtually transformed by innovations in medical technology. Breakthroughs such as coronary stents, implantable defibrillators and minimally invasive bypass surgery have helped reduce the death rate from heart disease by 40 percent since 1980.
I consider device safety and sterility to be of utmost importance and appreciate your invitation and the opportunity to discuss this issue. BACKGROUND Let me begin with a brief overview of our regulatory authorities regarding medical devices.
Based on current information, the FDA believes the overall benefits of these devices continue to outweigh the risks. However, health care providers should be aware of potential problems and consider certain actions prior to use.
The experimental work involves the production of silver nanoparticles with controlled surface chemistry. An analytical model was also developed to account for the electrochemical processes responsible for the dissolution of the silver nanoparticles.
In August, the FDA released its "Strategic Plan for Regulatory Science." That plan touches on several priority areas identified in greater detail in CDRH's regulatory science report.
Thank you for the opportunity to discuss the Agency's role and experience in oversight of direct-to-consumer (DTC) advertising of medical devices. I also will review the Agency's enforcement actions, outreach, and other compliance activities.