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Modernization of Cosmetics Regulation Act-MoCRA  
For the first time in over eight decades, on December 29, 2022, a significant piece of legislation, known as the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), has been signed into law by the U.S. Food and Drug Administration (FDA), to modernize the regulatory oversight of the cosmetic products industry.    
How to Renew FDA Registration?  
FDA registration renewal process primarily depends on the type of products that are being marketed in the US. Here we try to break down the FDA renewal steps and fees based on the registration type. In the article below, we cover the FDA renewal steps for food, medicaal device, drugs and cosmetics.    
How to obtain NDC number?  
National Drug Code or NDC is a 10-digit identification number assigned to each drug product in the US market (either OTC or prescription). The NDC number is primarily used for medical billing and insurance purposes, it also can be presented a proof of proper FDA drug listing.    
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...    
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 fulfi....    
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 ...    
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 ...    
U.S. FDA is asking for Unique Facility Identifier (UFI) during 2020 Food Facility Registration Renewal Period  
According to the U.S. FDA, beginning of October 1st, 2020 all registered food facilities must submit an FDA-recognized form of UFI during the 2020 food facility registration renewal period.    
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)    

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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