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Guidance for Industry and Food and Drug Administration Staff FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals Document issued on: October
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FDA stands for Food and Drug Administration, and industry actions refer to actions taken by companies in response to FDA regulations or requirements.
Companies in the food and drug industry are required to file FDA and industry actions.
Filling out FDA and industry actions typically involves submitting documentation and information to the FDA in accordance with their guidelines and regulations.
The purpose of FDA and industry actions is to ensure compliance with FDA regulations, protect public health, and maintain safety standards in the food and drug industry.
Information that must be reported on FDA and industry actions includes details of products, manufacturing processes, labeling, and any adverse events or recalls.
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