FDA Monograph Drug User Fee: $20,322.00 annual fee to keep the registration of your company manufacturing, exporting or selling sunscreens.
FDA NEWS
U.S. FDA News: information, analysis and news for executives in industries regulated by the U.S. Food and Drug Administration.
There are two types of FDA Registration renewals: annual (10/1/2021 – 12/31/2021) and biennial (10/1/2022 – 12/31/2022).
FDA Daily Values (DV) are the recommended amounts of nutrients to consume, or not to exceed each day, to make informed choices.
FDA Compliant Labels: ensure that you are not representing your products as safe and or effective for a COVID-19-related use, without approval.
Foreign Supplier Verification Program (fsvp) is now being enforced by the FDA, with the help of the U.S. Customs & Border Protection (CBP).
FDA Detention: the agency uses the internal data systems to verify registration, listing, device approval (when required), the manufacturer and importer.
Importing Hand Sanitizers: Because hand sanitizers are considered over-the-counter (OTC) drug products, FDA registration is required.
Food Canning Establishment (FCE) Registration and Process Filing are required for Acidified Food (AF) and Low-Acid Canned Food (LACF) for manufacturers.
Personal Protective Equipment (PPE): face masks, face shields and N95 respirators are medical devices based on their intended use.
FDA Warning Letters: selling products that, without approval or authorization, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in patients.
N95 Respirators and Surgical Masks (Face Masks), Filtering Facepiece Respirators (FFRs), are Personal Protective Equipment (PPE) and medical devices.
FDA Prior Notice: no prior notice, inaccurate prior notice, or untimely prior notice, are inadequate, and will result in refusal of admission.
Switch U.S. Agent for your Facility or Establishment, then pay the lowest FDA Registration Service Fees. Select ITB HOLDINGS LLC today, and let’s get started.
OTC Cosmetics labeled with organic claims must comply with both USDA regulations, and FDA regulations for labeling and safety requirements for cosmetics.
Surgical isolation gowns, like surgical gowns, are regulated by the FDA as a Class II medical device that requires a 510(k) Premarket Notification.