By Stephen M. Hahn MD – One of the challenges facing the FDA during the COVID-19 pandemic is how to ensure the timely reviews of medical product applications despite a surge in volume of work and practical constraints that may impact our ability to conduct on-site inspections.Read More
By Christophe Dore – Healthcare is digitalizing more information and connecting more information systems than ever before to enhance patient care and operational efficiency, with the expectation the synergies between these systems will create additional value.
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 Kayla Matthews – Any time a medical professional works with patient information, they must carefully follow HIPAA regulations and standards, including those that protect patient data. Medical devices — which can store, analyze and transmit patient data —
By Clyde Hewitt – It is safe to assume that most hospitals still struggle to find ways to address their medical device cybersecurity risks. The primary challenge is not technical, it’s the organizational inertia that keeps getting in the way.
By Kayla Matthews – Since 1976, the U.S. Food and Drug Administration (FDA) has offered a fast-track approval process for medical device manufacturers that could prove their products were substantially similar to approved items that were already in the marketplace.
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.