The US Food and Drug Administration (FDA) has updated and expanded its list of premarket medical device consensus standards that include important topics such as medical device cybersecurity, sterilizing products using radiation and using certain materials and alloys.
FDA published tables on 1 August listing voluntary consensus standards that are either withdrawn, replaced, corrected or are newly recognized, to help sponsors align with the agency’s expectations when they submit premarket applications for medical devices and diagnostics.
“FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the agency is recognizing for use in premarket submissions and other requirements for devices,” the agency said in announcing the updated standards list.
Notably, the list of new standards has a significant portion of it dedicated to new software and informatics standards, several of which address cybersecurity and interoperability. e been top of mind at the agency with the exponential growth of the digital health sector in recent years.
The Agency’s searchable consensus standards database can be accessed here.