Regulatory News In Brief

FDA draft guidance issued Feb. 17 outlines how firms should submit standardized study data electronically. The guidance applies to submissions of clinical and non-clinical study data, including investigational device exemptions, 510(k) applications and PMAs. FDA says standardized study data make it easier for the agency to understand, analyze and synthesize information, leading to more effective regulatory decisions. FDA intends to issue a proposed regulation at some point in the future requiring the submission of standardized electronic study data. Comments on the draft guidance are due in mid-April.