FDA is carefully monitoring the medical device supply chain amid a shutdown of facilities that use a gas called ethylene oxide to sterilize medical devices.
Regulatory and Compliance
A letter from Senator Mark Warner (D-VA) prompted AdvaMed to reiterate these five principles for addressing medical device-related cybersecurity threats.
The Department of Homeland Security and FDA alerted people about cybersecurity vulnerabilities affecting Medtronic's implantable defibrillators. Medtronic is developing updates to further mitigate these vulnerabilities.
Don't miss these technical resources on design validation and human factors, preventing misconnections, implant coatings, and more.
FDA said Johnson & Johnson's Mentor unit and Sientra have failed to comply with post-approval study requirements for their silicone gel-filled breast implants.
FDA is calling on the public, scientists, and industry to help enhance the agency's understanding of materials science and to advance the development of safer medical device materials.
FDA urges collaboration, but healthcare system limitations and FDA guidance prompt medical devices to be secure by design to ensure patient safety.
Norman Sharpless, director of the National Cancer Institute, will become “acting” commissioner of FDA after commissioner Scott Gottlieb abruptly announced he is leaving the position.
The agency released a letter to healthcare providers pointing out the risks and said it would hold a public advisory committee meeting.
An investigative report claims FDA is hiding millions of adverse event reports from the public under the guise of an alternative summary reporting program.
A successor has not yet been named and it is expected that Gottlieb will leave the position sometime next month.
Many industry stakeholders took to Twitter on Tuesday to respond to the news that FDA Commissioner Scott Gottlieb is stepping down.