USA – FDA drafts guidance on device production and quality system software assurance
The US Food and Drug Administration (FDA) has issued a draft guidance on software assurance for computer and data processing systems associated with medical...
USA – Studies linking recalled 510(k) devices to problematic predicate products are ‘warning shot’...
Two recent studies that link the recall of 510(k)-cleared medical devices to problematic predicate products should serve as a “shot across the bow” for...
USA – FDA warns consumers against using plastic syringes made in China
It’s not unusual for the US Food and Drug Administration (FDA) to publish warning letters about manufacturers that fail to meet its regulatory requirements,...
USA – Legacy devices report highlights need for data to support future policies
More data is needed to understand the risks legacy connected medical devices pose to the healthcare system, particularly in their vulnerability to cyberattack. That...
USA – FDA proposes breakthrough status for devices that address health disparities
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has proposed that devices that aim to eliminate disparities in...
USA – FDA issues road map to medical device regulatory guidance topics list for...
The US Food and Drug Administration has released a list of guidance documents it plans to issue over its 2023 fiscal year. FDA’s Center...
USA – MedCon: Consider the device risk management file a ‘living document’
Device manufacturers need to keep their risk documentation up to date throughout the total product life cycle by monitoring production and post-production information, according...
USA – US FDA sets some steep increases for 2023 medical device user fees
The US Food and Drug Administration announced that it has set medical device user fees for fiscal year 2023. Medical device manufacturers and importers seeking...
USA – Evidentiary Expectations for 510(k) Implant Devices
As part of FDA’s Medical Device Safety Action Plan: Protecting Patients, Promoting Public
Health (herein referred to as the “Safety Action Plan”), FDA committed to...
USA – FDA highlights updated labeling for some surgical mesh products, cautions against use...
The US Food and Drug Administration (FDA) issued a letter to healthcare providers to make sure they are aware of updated warnings and precautions...
