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FDA Requirements for Hand Sanitizers and Other Antiseptic OTC Drugs  
Hand Sanitizers and most form of antiseptic/antibacterial products are considered over-the-counter (OTC) drugs by the FDA. In order to introduce an OTC drug to the U.S. market, the manufacturers and the US importers must fulfill certain FDA requirements    
FDA Regulations for Importing Medical Masks to the U.S  
It’s not a secret that COVID-19 pandemic has caused a major boom in demand for use of medical mask in the US. FDA Listing Inc. has been dealing with several U.S. importers as well as manufacturers outside ...    
Medical Devices; Who Must Register List and Pay the Fee  
Establishments that are involved in the production and distribution of medical devices intended for commercial distribution in the United States (U.S.), including those that are imported for export only, are required to...    
How Exactly Cosmetics Are Not FDA Approved, but They Are FDA Regulated  
The law does not require cosmetic products and ingredients, other than color additives, to have FDA approval before they go on the market, but there are laws and regulations that apply to ...    
N95 Respirators and Surgical Masks (Face Masks)  
N95 respirators and surgical masks (face masks) are examples of personal protective equipment that are used to protect the wearer from airborne particles and from liquid contaminating the face. Centers for Disease Control and Prevention (CDC) National Institute for Occupational Safety and Health (NIOSH)    
Regulation of OTC (over-the-counter) Drugs  
Over-the-counter (OTC) drugs are developed under the OTC Monograph Process or through the New Drug Application (NDA) Process. FDA's review of OTC drugs is primarily handled by the Center for Drug Evaluation's    
What Do The Importers Need to Know About The FDA's FSVP  
The first major compliance date for importers covered by the Foreign Supplier Verification Programs (FSVP) rule arrives on May 30, 2017. FSVP is mandated by the FDA Food Safety Modernization Act (FSMA).    


FDAListing.com Inc., referred as FDA Listing Inc., is a privately held regulatory assistance company with headquarters in New York, USA. FDA Listing Inc. has no affiliation with or endorsement by United States Food and Drug Administration. The certificates issued by FDA Listing Inc. are only for the sake of confirmation of FDA registration for your industry partners and are not recognized by United States Food and Drug Administration - FDA.
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