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:

  • The agency has begun accepting Global Unique Device Identification Database (GUDID) account requests from Class II device labelers
  • Device types for which FDA reviewers require human factors testing data have been specified.
  • An Emergo analysis of FDA 510(k) data shows changes in where premarket notifications are coming from, and in terms of how long it takes to clear a device for sale in the US.
  • A MDUFA III-commissioned performance report commends the FDA for its efforts to improve premarket review processes.
  • US Congressional proposals to revamp FDA device premarket reviews and clinical trial requirements are gaining traction.
  • Coverage organizations’ input sought by the FDA for medical device clinical trial designs, with implications for insurance and reimbursement.
  • Updated guidance from the FDA on eCopy submissions
  • FDA plans stronger oversight of lab developed tests (LDTs)

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.


  • Stewart Eisenhart