Mar 1, 2016
The US FDA has been busy since late 2015, issuing several new and updated guidance documents related to Human Factors, eCopy submissions, oversight of lab developed tests and more.
Significant US FDA-related news over the last 3 months:
For additional information on US medical device regulations, see our whitepaper on FDA device registration and our video overview on US medical device registration and approval.
Citing security vulnerabilities, the US Food and Drug Administration has extended deadlines for compliance with a key component of the agency’s Unique Device Identification (UDI) system.
The US Food and Drug Administration’s revised Refuse to Accept (RTA) policy is now in effect.
The RTA policy involves an early review of 510(k) applications to determine whether they are “administratively complete,” or contain all materials necessary for the regulator to conduct a substantive review.