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Medical Device Interoperability

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.

Views: 13  

Source: www.fda.gov

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Year 2000 date and Medical Devices

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.

Views: 430  

Source: www.fda.gov

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Medical Device Electrical Safety

Summary Assuring the safety of the patient and the operator of a medical device is the major focus of our group. As a result, safety and risk assessment become major properties of any medical device evaluation.

Views: 31  

Source: www.fda.gov

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How does the FDA 'approve' medical products? - Medical News Today

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.

Views: 185  

Source: www.medicalnewstoday.com

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Scott Gottlieb, MD - 2005 Medical Innovation Summit

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.

Views: 184  

Source: www.fda.gov

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Reauthorization of FDA's Medical Device Program

I am the Lead Deputy Commissioner for the Food and Drug Administration (FDA). As this definition suggests, many different types of products are properly regulated as medical devices.

Views: 163  

Source: www.fda.gov

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Medical Device Safety and Sterility

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.

Views: 265  

Source: www.fda.gov

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The Year 2000 and Medical Devices

I am pleased to be here to provide information about the "Year 2000" date issue as it relates to medical devices. As this definition suggests, many different types of products are properly regulated as medical devices.

Views: 210  

Source: www.fda.gov

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Intravascular Medical Devices: FDA Safety Communication - Lubricious Coating Separation

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.

Views: 106  

Source: www.fda.gov

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Research Project: Nanoparticles on Medical Devices

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.

Views: 86  

Source: www.fda.gov

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FDA Issues Report Detailing Improvements Being Made To Science Used For Medical Device Approval…

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.

Views: 110  

Source: www.medicalnewstoday.com

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FDA Oversight of Direct-to-Consumer Advertising of Medical Devices

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.

Views: 164  

Source: www.fda.gov