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The US Food and Drug Administration (FDA) has issued a draft guidance on software assurance for computer and data processing systems associated with medical...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 – 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 finalizes rule for over-the-counter hearing aid devices
The US Food and Drug Administration has finalized rules establishing over-the-counter (OTC) availability for certain types of hearing aids in order to improve public...
USA – FDA: Nearly 700 breakthrough medical device designations since 2015
The US Food and Drug Administration has granted almost 700 designations over the past seven years under a voluntary program for expedited regulatory review...
USA – FDA eases UDI compliance requirements for some low-risk medical devices
The US Food and Drug Administration has exempted low-risk medical devices considered consumer health products from some Unique Device Identification compliance requirements in accordance...
USA – FDA finalizes guidance on machine learning for medical devices
The US Food and Drug Administration has finalized guidance on the regulation of software as a medical device (SaMD) that utilizes artificial intelligence or...
USA – La FDA planche sur des directives relatives à la sécurité des objets...
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “Cybersecurity in Medical Devices: Quality System Considerations...
USA – US FDA withdraws COVID-era guidance for medical device and IVD market approval...
The US Food and Drug Administration announced that it has withdrawn its temporary policies related to the COVID-19 pandemic because they are no longer...
USA – FDA considers pilot for lower radiation levels for device sterilization
The US Food and Drug Administration (FDA) may allow medical device manufacturers to modify their radiation sterilization processes to prevent supply shortages. The agency...
USA – FDA adds transition period to electromagnetic compatibility final guidance
The US Food and Drug Administration (FDA) has finalized guidance on medical device electromagnetic compatibility that replaces a 2016 document on the same topic....
