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USA – FDA draft guidance covers low-level light therapy devices
The US Food and Drug Administration (FDA) has published a draft guidance for low-level light therapy (LLLT) devices, or photobiomodulation (PBM) devices, which are...
USA – FDA official says pandemic reauthorization bill could drive VALID across finish line
A top US Food and Drug Administration (FDA) official said that a pandemic funding reauthorization bill could act as a vehicle for in vitro...
USA – Stakeholders seek flexibility, greater harmonization in FDA human subject protection rules
Commenters from the pharmaceutical and medical device industries, academia and medical groups urged the US Food and Drug Administration (FDA) to help ease the...
USA – FDA classifies slew of class II devices following de novo procedures
Since the last week of 2022, the US Food and Drug Administration (FDA) announced it was classifying nine products as class II devices with...
USA – FDA opens TAP
The US Food and Drug Administration (FDA) has initiated a soft launch of its Total Product Lifecycle Advisory Program (TAP), which was negotiated under...
USA – FDA guidance proposes devices be deemed adulterated for refusing inspections
The US Food and Drug Administration’s (FDA) has issued draft guidance proposing that devices be deemed adulterated and refused entry to the US market...
USA – New US FDA Guidance on Human Factors Engineering for Medical Devices
The US Food and Drug Administration has issued a new draft human factors engineering (HFE) guidance this week titled: Content of Human Factors Information in...
USA – FDA proposes framework for human factors information in device submissions
The US Food and Drug Administration (FDA) last week issued draft guidance outlining a risk-based framework about what human factors information should be included...
USA – FDA aims to clarify device malfunction summary reporting requirements
In a new draft guidance issued on Thursday, the US Food and Drug Administration (FDA) aims to clarify how manufacturers can voluntarily submit malfunction...
