FDA: Labeling requirements to add 2m hours to medtech industry’s regulatory burden

New FDA labeling regulations submitted to the FDA’s Office of Management and Budget are expected to add an additional approximate 1.6 million hours of work to record keepers at the agency, according to an FDA notice

The added burden comes from changes to the federal watchdog’s medical device labeling regulations, which the agency is actively seeking comments on.

With the changes, the agency expects a burden of approximately 3.3 million hours for itself and 9.2 million hours for third-party disclosures, up approximately 1.6 million hours since the last OMB approval, according to the release.

The agency is seeking comment on the new regulations, which also include a number of third-party disclosure rules, until October 4, according to the notice.

Last month, the FDA warned of serious flesh-eating bacterial infections, or necrotizing fasciitis, reported by patients taking sodium-glucose cotransporter-2 (SGLT2) inhibitors intended for treating type 2 diabetes.

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