By Amy Abernethy, MD, PhD & Suzanne B. Schwartz, MD, MBA – Medical devices are increasingly more advanced and interconnected, sharing information via Wi-Fi, the internet, our phones and across hospital networks.
By Janet Maynard, MD & Andrea Furia-Helms – There are approximately 7,000 rare diseases affecting an estimated 30 million people in the United States. Many of these diseases are serious or life-threatening and it is estimated that half affect children.
By Scott Gottlieb MD & Gerald Dal Pan MD, MHS – The US FDA is an information-driven agency that requires robust data to make regulatory decisions. One of our key obligations is to analyze large quantities of data related to the safety and effectiveness of medical products…
By Anna Abram & Mark Abdoo – Even in this modern era, when so much can be done remotely, there are many tangible benefits to having “boots on the ground” when doing business overseas. That’s the thinking behind the FDA’s foreign offices, which play a vital role in inspecting….
By Suzanne B. Schwartz – Ensuring medical devices are safeguarded from cyber intrusions is a shared responsibility across the medical device ecosystem. At the FDA, we deal with cybersecurity in the context of the total product lifecycle of a device.
By Jeff Shuren MD JD – FDA guidances explain the agency’s interpretation of, or policy on, a regulatory issue. The agency and its centers prepare guidances for industry, but also for other customers, including our own staff…
By Scott Gottlieb MD – When the FDA recently granted marketing authorization for two medical apps for Apple’s new Watch, it marked a significant step forward for the agency’s overall approach to the development of digital health.
By Scott Gottlieb MD – Advancing the public health means helping to make sure patients have access to safe, effective medical products. Access is a matter of public health. And our commitments to patients don’t stop at the time of a product’s approval.
By Christopher Leptak MD PhD – To be most effective, electronic health records use a systematized and standardized nomenclature for the hundreds of thousands of clinical terms that characterize patient care.
By Jeffrey Shuren MD, JD – Since 2012, we at the Center for Devices and Radiological Health have set as our North Star the vision of patients in the U.S. having access to high-quality, safe, and effective medical devices of public health importance first in the world.
By Scott Gottlieb MD & Jeffrey Shuren, MD JD – Recently, the Food and Drug Administration has committed to several new policies that will modernize the agency’s approach to regulation in the medical device system.
By Suzanne Schwartz MD MBA – Virtually every aspect of our lives – including our health – has gone digital. Medical devices from insulin pumps to implantable cardiac pacemakers are becoming more interconnected and, like computers and the networks they operate in, can be vulnerable to security breaches.
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