A new rule (effective Sept. 22) clarifies when companies can modify device labeling without prior FDA approval. Under the rule, manufacturers can add or strengthen the contraindications, warnings, precautions or adverse-reactions sections of labeling by a PMA supplement without prior FDA approval, but only when such modifications are based on newly acquired information of a causal association between the product and a safety issue.

Proposed earlier this year, the final rule, published in the Federal Register, includes one change related to devices — a clarification on what the FDA considers newly acquired information. The final rule defines such information as data, analyses or other information not previously submitted to the agency. Such information “must reveal risks of a different type or greater severity or frequency than previously included in submissions” and includes meta-analyses, states the regulation.