The U.S. Food and Drug Administration (FDA) has released its final guidance on premarket notification (510(k)) submissions by electronic format.
Published in early October, the Guidance, “Electronic Submission Template for Medical Device 510(k) Submissions,” provides a detailed explanation of the structure of the agency’s current eSTAR 510(k) electronic submission template, along with a thorough description of the kind of information expected for each individual template listing (e.g., “device description,” “consensus standards,” “predicates and substantial equivalence,” “labeling,” etc.).
Where appropriate, the Guidance also lists the applicable standards and other documents that device developers should use in assessing the compliance of their device with the FDA’s requirements.
Guidance documents issued by the FDA and other agencies are intended solely to provide insight into the current thinking of regulators and should be viewed only as recommendations and not requirements.