The US Food and Drug Administration is one step closer to requiring electronic submission of all premarket applications for both 510(k) and de novo medical devices, according to two newly released draft guidances on the matter.
As of 1 October 2023, all 510(k) applications must be submitted through the electronic Submission Template And Resource (eSTAR) program portal, according to the draft guidance on 510(k) applications.
“This date includes a transition period of a minimum of one year prior to the requirement that all 510(k) submissions be provided as electronic submissions,” the guidance notes. “During the transition period, eSTARs may be used voluntarily for 510(k) submissions …FDA only intends to accept 510(k) submissions saved to a form of electronic storage media and mailed to FDA if they are received by FDA before October 1, 2023.”…
