Under a new FDA rule, medical device manufacturers can add or strengthen contraindications, warnings, precautions or adverse reactions sections of labeling via a premarket application (PMA) supplement without prior FDA approval, when “such modifications are based on newly acquired information and evidence of a causal association between the product and a safety signal is present.”
The FDA proposed the rule earlier this year, which takes effect Sept. 22. The final rule, which is published in the Federal Register, incorporated one change related to devices-—a clarification on what the FDA considers newly acquired information.
The final rule defines newly acquired information as data, analyses or other information not previously submitted to the agency. Such new information “must reveal risks of a different type or greater severity or frequency than previously included in submissions” and includes meta-analyses.
“The codified section of the January 2008 proposed rule suggested that this limitation applied only to data derived from reports of adverse events,” the FDA wrote. “Instead, it applies to data derived from new clinical studies, reports of adverse events and new analyses of previously submitted data.”
The agency added, “If a sponsor submits data or analysis to FDA as part of a discussion of the kind of labeling change that would be appropriate and decides as a result of that discussion to prepare and submit a [PMA supplement], then the supporting data or analysis will not be considered ‘previously submitted to FDA’ — even if it was not first submitted on the same day as the [PMA] supplement.”
The rule states that evidence of a causal association refers to standards in the FDA Device Labeling Guidance.