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The Food and Drug Administration (FDA) is seeking public comments on a proposed information collection related to medical device shortages. Under the Paperwork Reduction Act, they must announce proposed data collection plans and allow a 60-day public comment period. This data will help the FDA manage medical device availability during emergencies by obtaining information on production changes that could cause shortages. Additionally, the CARES Act gives FDA the power to require notifications from manufacturers about disruptions that could impact device supply, especially during public health emergencies.

The Food and Drug Administration (FDA) has released a draft guidance for industry on the process of notifying them about a permanent discontinuance or an interruption in the manufacture of infant formula. This guidance aims to assist those in the infant formula industry in complying with notification requirements to the FDA, as mandated under the Federal Food, Drug, and Cosmetic Act. The guidance outlines how and when manufacturers should notify the FDA in order to avoid potential disruptions in supply. The public is invited to submit comments on the draft guidance until February 18, 2025, and on the proposed collection of information by February 3, 2025.