미 FDA에서 510(k) 허가를 위한 서류 제출방식 가이던스를 발간하였다.
▶ 적용시점
FDA is identifying October 1, 2023 as the date on which the 510(k) electronic submission requirements will take effect.
▶ Scope
This guidance describes the technical standards associated with preparation of the electronic submission template for 510(k)s that enable submission of the 510(k) electronic submission solely in electronic format. The electronic submission template includes the information and guided prompts FDA believes will best facilitate the collection and assembly of the necessary elements of a ‘complete’ submission, as required by regulation or essential to FDA’s substantive review of the 510(k) submission. This guidance is not intended to specify the user-interface and detailed content of the eSTAR, but instead is limited to establishing the 510(k) electronic format and standards for complying with section 745(A)(b)(3) of the FD&C Act. FDA intends to implement new versions of eSTAR as relevant policies change. FDA also has an ongoing process to collect and consider public comments and stakeholder feedback, which is described on FDA’s website.
Electronic Submission Template for Medical Device 510(k) Submissions | FDA
Electronic Submission Template for Medical Device 510(k) Submissions
This guidance provides further standards for electronic 510(k) submission, a timetable for establishment of the standards, and criteria for waivers/exemptions.
www.fda.gov
