The new director of the FDA’s device center contrasted a European rule with the U.S.’s lack of mandatory reporting ...

While medical device shortages are nothing new, the FDA said it is becoming more concerned that supply chain disruptions are ...

Both President Biden, and incoming President Trump, have made AI a top priority, and now the U.S. Food and Drug ...

The FDA first warned about problems with pulse oximeter accuracy in 2021. CDRH had listed draft guidance on pulse oximeters ...

The FDA first warned about problems with pulse oximeter accuracy in 2021. CDRH had listed draft guidance on pulse oximeters among its priorities for the 2024 fiscal year but missed the cutoff.

Her vision for CDRH includes supporting device developers with tailored ... One of Tarver’s main goals is to improve collaboration between the FDA and device developers. Programs like the FDA’s ...

The competition – on which more details are available here – is being run by the FDA’s Center for Devices and Radiological Health (CDRH) and the Office of Digital, and ties in with ongoing ...

He was also involved in the creation of the FDA's Digital Health Center of Excellence in 2020 and drawing up the Center for Devices and Radiological Health (CDRH) 2022-2025 strategic priorities ...

The Center for Devices and Radiological Health (CDRH) is unveiling an Idea Lab as part of the Home as a Health Care Hub initiative to help innovators, providers and patients reimagine the ...

MD, Medical device; MDD, Medical device development; FDA, Food and Drug Administration; CDRH, Center for Devices and Radiological Health; GHTF, The Global Harmonization Task Force; MDR, International ...