American Hospital Association1d
4 Steps to Improve Medical Device Recall Tracking
As of late February, there were 147 medical device recall events and 20 of them, or 13.6%, were Class I, according to a Modern Healthcare report.
JD Supra13d
A Regulatory Haze of Uncertainty Continues as the Clock Ticks Toward Phase One of FDA’s LDT Final Rule
Clinical laboratories still face uncertainty and the difficult decision of whether to start the work needed to comply with the with Phase ...
Medical Design & Outsourcing7d
Regulatory consultant offers help for FDA’s tougher pulse oximeter draft guidance
MethodSense says it is helping pulse oximeter manufacturers with FDA draft guidance to enhance accuracy across diverse skin ...
MedTech Dive2d
Dexcom receives warning letter based on FDA inspections of 2 plants
The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek ...
Manila Standard2d
FDA goes digital with eServices Portal System
THE Food and Drug Administration (FDA) has launched an online application process for Certificate of Medical Device Notification (CMDN) for Class A ...
Dexcom receives FDA warning letter for two U.S. manufacturing facilities
Medical device maker Dexcom said it has received a warning letter from the U.S. Food and Drug Administration following ...
What to Know About Marty Makary, Trump’s Pick to Lead the FDA
If confirmed, Makary would run one of the nation's leading health agencies, overseeing the regulation of food and drugs.
OTCQB-CSDX Appoints Lachman Consultants for CS-Protect Hydrogel FDA Approval
CS DIAGNOSTICS CORP. ANNOUNCES THE APPOINTMENT OF FDA CONSULTANTS Innovative tissue spacer technology for cancer radiology treatments CHEYENNE, WY / ACCESS Newswire / March 12, 2025 / CS Diagnostics ...
FDA Inspection Seminar: Preparations for Pharmaceutical and Medical Device Professionals (ON-DEMAND)
The "FDA Inspection" training has been added to ResearchAndMarkets.com's offering. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no ...