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 – Patient preference information: Researchers offer insights on medical device clinical trial design
The US Food and Drug Administration (FDA) has increasingly called for the inclusion of patient preference information (PPI) to inform its regulatory decision-making for...
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The US Food and Drug Administration’s (FDA) has issued draft guidance proposing that devices be deemed adulterated and refused entry to the US market...
