ARTICLE SUMMARY:
The agency is getting its ducks in a row for instituting a 510(k) electronic submissions mandate with a draft guidance this week and plans for a timeline next September. The FDA eSTAR electronic template is expected to form the basis of device submissions in the US and abroad.
FDA says it will announce by next September the specific dates by which it will require companies to use an electronic template for 510(k) submissions. The agency disclosed that plan in draft guidance issued September 29 describing the ins and outs of its electronic Submission Template and Resources (eSTAR) tool, which FDA and other global regulatory authorities are viewing as the future platform for device submissions.
