By Devin Partida – When the COVID-19 pandemic first began causing problems around the world, health care professionals often had to adjust their practices as new research became available. However, one thing that was clear from the start was the need to maintain effective sterilization techniques.Read More
By Jeff Shuren MD JD & Ed Margerrison PhD – Progress in science and technology offers extraordinary opportunities to develop innovative medical products that can save lives and lead to better treatments, better diagnostics and better care for patients.
By Jeff Shuren MD JD & Daniel Caños PhD MPH – Among the many ways that the U.S. Food and Drug Administration protects and promotes the public health is by ensuring the safety and effectiveness of medical devices, assuring that patients have timely access to them, and advancing medical device innovation.
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.
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.