COVID-19 Report
We’ve rounded up some of the latest news and announcements pertaining to the coronavirus and the healthcare industry.
Read MoreFDA Voices
Balancing Patient Engagement and Awareness with Medical Device Cybersecurity
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.
FDA is Working to Bridge Gaps and Meet Needs for Rare Disease Product Development
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.
The Future of FDA’s Electronic Safety Surveillance
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…
FDA’s Global Efforts to Protect Patients and Consumers from Unsafe 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….
Fostering Collaborative Communities to Improve Patient Healthcare
By Scott Gottlieb, MD, Jeff Shuren, MD, JD, & Michelle Tarver, MD, PhD – Collaboration. It’s a word we use a lot at the FDA — and for good reason. Collaboration is an essential element of many approaches we apply to achieve our public health mission.
The Medical Device Ecosystem and Cybersecurity — Building Capabilities and Advancing Contributions
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.
CDRH FY 2019 Proposed Guidance Development and Retrospective Review
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…
FDA Budget Matters: Advancing Innovation in Digital Health
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.