There continues to be much discussion over the FDA’s 510(k) program, which has led to controversy and confusion over the direction of the program.  In fact, we have posted many blogs devoted to this topic, so we thought it was time to create a whitepaper focusing on the topic.

Recently the FDA released a Guidance for Industry on “Providing Regulatory Submissions in Electronic Format — Standardized Study Data.” This guidance expresses the FDA’s recommendation that sponsors submit clinical and nonclinical data in a standard electronic format.  In the guidance the FDA points out that standardizing study data makes the data more useful. “Data that are standardized are easier to understand, analyze, review, and synthesize in an integrated manner in a single study or multiple studies, thereby enabling more effective regulatory decisions.”