October 1 is a big day in the context of U.S. Food and Drug Administration (FDA) regulations. As fiscal year (FY) 2015 begins, so do food facility, drug facility, and medical device establishment registration renewals. October 1 is also the due date for generic drug facility fees.
Food and Beverage
Under the Food Safety Modernization Act (FSMA), food facilities are required to renew their FDA food facility registrations every even numbered year between October 1 and December 31. Learn more about FDA food facility registration renewal.
Medical device establishments are required to register with FDA annually between October 1 and December 31. The registration fee for FY 2015 is $3,646.
Drug facilities are also required to register annually between October 1 and December 31, though there is no fee. Along with this, active pharmaceutical ingredient (API) and finished dosage form (FDF) generic drug facilities are required to pay annual facility fees. The fees are due on October 1 every year. FDA must receive full payment within 20 days of the due date. Learn more about FDA generic drug facility fees.
Registrar Corp is an FDA consulting firm that helps companies comply with FDA regulations. We can register food and medical device companies with FDA and list device and drug companies’ products. If you have questions about any of the requirements listed above, contact us at +1-757-224-0177 or speak to a Regulatory Specialist 24 hours a day at https://www.registrarcorp.com/livehelp.