Final Rule Clarifies Device Labeling Changes

A new rule clarifies when companies can modify device labeling without prior FDA approval.

Under the rule, which takes effect Sept. 22, manufacturers can add or strengthen the contraindications, warnings, precautions or adverse reactions sections of labeling via a PMA supplement without prior FDA approval only 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. The final rule, which was published recently 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 new regulation states.

“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 says in the preamble to the final rule. “Instead, it applies to data derived from new clinical studies, reports of adverse events and new analyses of previously submitted data.”

The agency adds, “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.”

Evidence of a causal association refers to standards in the FDA Device Labeling Guidance, the rule says.