JD Supra7d
Unpacking Averages: CDRH Recognition of Consensus Standards Appears to Overlook Software
For decades, FDA’s Center for Devices and Radiological Health (CDRH) has been recognizing standards that can be referenced in premarket medical ...
medtechdive12d
Michelle Tarver faces challenges as new CDRH leader. But patient groups, industry are optimistic.
Patient advocates are hoping for change under new director Michelle Tarver, while industry groups look to build on former ...
BioPharma Dive12d
FDA’s new device chief faces challenges. Patient groups, industry are still optimistic.
Patient advocates are hoping for change under new director Michelle Tarver, while industry groups hope she will build on ...
ophthalmologytimes16d
Michelle Tarver, MD, PhD, named permanent director of the FDA's Center for Devices and Radiological Health
The FDA has named Michelle Tarver, MD, PhD, as the permanent director of the FDA's Center for Devices and Radiological Health (CDRH). Tarver is a board-certified ophthalmologist with a doctorate in ...
Business Wire20d
MDIC Celebrates Dr. Michelle Tarver as Newly Appointed Director of FDA’s Center for Devices and Radiological Health
ARLINGTON, Va.--(BUSINESS WIRE)--The Medical Device Innovation Consortium (MDIC), the first public-private partnership created with the sole objective of advancing medical device regulatory ...
FierceBiotech21d
It's official: Michelle Tarver named director of the FDA's devices center
An ophthalmologist by training with a Ph.D. in epidemiology, Tarver has worked at the FDA since 2009. She has held multiple leadership positions at CDRH, including deputy director of the Office of ...
BioPharma Dive22d
FDA names Tarver as new head of device center
FDA Commissioner Robert Califf emphasized Tarver’s “passion ... and continues to care for people with inflammatory eye conditions. In the past, Tarver was CDRH’s chief transformation officer, helping ...
Food Standards Agency22d
Hazard Analysis and Critical Control Point (HACCP)
HACCP is a way of managing food safety hazards. Food safety management procedures should be based on HACCP principles. HACCP involves: looking closely at what you do in your business, what could go ...
The Washington Post25d
New drug overdose data provides hope while deaths remain too high
(Alyssa Pointer for The Washington Post) Federal statistics on drug misuse and overdoses are alarming and frightening, but there’s also notable progress within the context of bad news and still ...
medtechdive26d
Tarver, acting CDRH director, sets tone for future of the device center
The passing of the baton — though the FDA has made no official announcement — comes as Shuren is embroiled in controversy regarding his 15 years leading the CDRH. One month after retiring, The New ...