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.
Regulatory and Compliance
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.
Product launches, study results, and approvals were signs of a pretty significant week in diagnostics, as FDA, CMS, and CDC formed a task force to make diagnostics rapidly available during public health emergencies.
FDA issued a safety notice to doctors and patients regarding the use of robotically-assisted surgical devices for mastectomy and other cancer-related procedures.
FDA has warned several facilities against illegally marketing and distributing unapproved thermography devices as a sole screening device for breast cancer and other diseases.
The company's eye-tracking technology has the potential to solve an important unmet need for providing objective measurements to aid in the assessment of concussion.
Tandem Diabetes Care has received a nod from FDA for the t:slim X2 insulin pump and the approval opens up a new device category – Alternate Controller Enabled Infusion Pumps.