Hamburg’s Resignation Letter to FDA Staff – JAN 2015
Hamburg’s final day at the agency will be in late March 2015, Hamburg wrote in an email. She will be succeeded on an acting basis by Stephen Ostroff, FDA’s chief scientist since January 2014.
FDA Commissioner Margaret Hamburg Resigned in March 2015
Margaret Hamburg, one of the longest-serving commissioners in U.S. Food and Drug Administration (FDA) history, planed to announce her resignation in February 2015, FDA officials have confirmed.
FDA says Expedited Access PMA, new LDT regulations, will be implemented this year
The FDA promised to finalize an expedited approval pathway for medical devices that address critical unmet needs and to officially expand its authority into the regulation of lab-developed molecular diagnostic tests in its annual list of upcoming medical device-related guidance documents for the new year.
Avoid Fetal “Keepsake” Images, Heartbeat Monitors
Ultrasound imaging is the most widely used medical imaging method during pregnancy. Fetal ultrasound imaging provides real-time images of the fetus. Doppler fetal ultrasound heartbeat monitors are hand-held ultrasound devices that let you listen to the heartbeat of the fetus. Both are prescription devices, designed to be used by trained health care professionals. They are not intended for over-the-counter (OTC) sale or use, and the FDA strongly discourages their use for creating fetal keepsake images and videos.
FDA issues new guidance on MRI safety and compatibility of medical devices
So far, the issue of MRI-safe devices has mostly focused on devices like pacemakers, and more recently cochlear implants, both of which use electronics. However, the FDA issued new guidance on the MRI compatibility–or in some cases incompatibility–of implants that do not require electrical power to service their function, such as cardiovascular stents, intracranial aneurysm clips, endovascular grafts and transprostatic tissue retractors.
The Top 15 Medical Device Deficiencies Cited by FDA in 2014
The US Food and Drug Administration (FDA) has released data on the observations it makes during inspections of medical device facilities, indicating the most common issues faced by medical device companies.
Is FDA Listening Enough to Patients? Agency Wants Feedback!
When Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law in 2012, its patient-centered provisions were among the biggest changes set to impact the culture of the US Food and Drug Administration (FDA). Now, two years later and with major planning already underway regarding the future of FDA’s patient-centered activities, agency regulators are reaching out to the public to ask what more they can do to improve their efforts.
Nintendo developing cloud-based sleep-monitoring device amid market growth
As med tech companies roll out innovative products to treat sleep disorders, electronics outfit Nintendo is looking to cash in on the trend with a new sleep-monitoring device that runs on its health-focused platform.
Blood test developed by Melbourne University detects Alzheimer’s disease before symptoms
A blood test developed by Melbourne University (Australia) researchers can detect Alzheimer’s disease years before symptoms become apparent; a study has shown. Researchers made the finding after testing 100 people for genetic material called microRNA, which circulates in the bloodstream.
FDA awards grants to stimulate drug, device development for rare diseases
The U.S. Food and Drug Administration announced in September 2014 The FDA awards grants for clinical studies on safety and/or effectiveness of products that could either result in, or substantially contribute to, approval of the products for patients with rare diseases, with at least a quarter of the funding going to studies focused solely on pediatrics.