FDA Update – June 25, 2025 Import Alerts for Certain Olympus Medical Devices Manufactured in Japan – Letter to Health Care Providers We are seeing more and more regulatory actions against foreign companies because of lack of FDA QSR compliance. When a company has a violative inspection, and the FDA does not accept their corrective
FDA has extended the compliance date for UDI label and GUDID submission requirements to September 24, 2018, for certain class II devices!! FDA has also clarified that the UDI and GUDID compliance date for certain device constituents of certain combination products will be September 2018. The UDI and GUDID extension applies to the below devices
On the same date, the Centers for Medicare and Medicaid Services (CMS) published a final rule that specifies the requirements that eligible providers and hospitals must meet to qualify for Electronic Health Record (EHR) incentive payments and solicits feedback about the Electronic Health Record (EHR) Incentive Programs going forward. Goal of this Activity: Incorporation of
FDA released this draft guidance to provide its current thinking on direct marking of devices in regards to UDI requirements. For devices that are intended to be used more than once and reprocessed before each use, they must bear a UDI on the device itself if it is also are required to have a UDI
We have been recently getting a lot of queries whether or not FDA can still issue NDC/NHRIC labeler codes for medical devices with the recent advent of the new UDI (Unique Device Identification) regulations being implemented by the FDA. The answer to this question is NO!!! Some of the clients are arguing about the NDC
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