RAPS

FDA’s CDRH releases list of proposed guidances for FY 2024

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has named the guidance documents it plans to publish during Fiscal Year 2024, as well as a list of the ...
Regulatory Affairs Professionals Society

This Week at FDA: FDA’s leadership churn continues, PDUFA negotiations wrap up, and more

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical ...
Medical Device and Diagnostic Industry (MD+DI)Opinion

Industry Expert Says Makary's Exit Changes Nothing for Device Companies Drowning in Delays

When Marty Makary resigned as FDA Commissioner on May 12, the news cycle was filled with pharma stories; a flavored vape ...

Food and Drug Administration (FDA): What It Is and Does

The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.
Medical Device and Diagnostic Industry (MD+DI)Opinion

FDA Device Fees Soar: Is Regulatory Expansion Justified?

CDRH fees doubled repeatedly. Is regulatory expansion justified? One observer says no. Breakthrough devices and TAP programs ...
JD Supra

Navigating Uncertainty in US FDA’s Center for Devices and Radiological Health Regulation of Medical Devices

The past six months at the US Department of Health and Human Services and the US Food and Drug Administration’s Center for Devices and Radiological Health have seen a fluctuating workforce size, a ...
JD Supra

FDA Device Guidance Agenda: What to Watch in 2026 AI, real-world evidence, PCCPs, and patient preference information top the list

The U.S. Food and Drug Administration (FDA) has published its guidance agenda for Fiscal Year 2026, announcing plans for eight guidance documents to be released this upcoming year. It also named 12 ...
BioWorld

CDRH will emphasize risk management in CY 2026

The FDA’s Center for Devices and Radiological Health (CDRH) will have its hands full with the roll-out of the overhauled quality management regulation, but this will have ripple effects on industry as ...
WOOD-TV

SS Innovations Conducts Interactive Meeting with the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) and Updates its Expected FDA ...

FORT LAUDERDALE, Fla., Sept. 11, 2024 (GLOBE NEWSWIRE) -- SS Innovations International, Inc. (the “Company” or “SS Innovations”) (OTC: SSII), developer of innovative surgical robotic technologies ...