FDA LISTING INC: EXPERIENCED ADVISORS FOR FULL-SERVICE FDA REGISTRATION & COMPLIANCE
+1 212 444 8202
U.S. FDA Registration
& Labeling Compliance Assistance
FDA Listing Inc
Building Trust, Ensuring Compliance.
FDA Listing Inc. is a New York Corporation founded in 2018 that provides FDA registration and listing, labeling compliance, U.S. agent services, and FDA detention assistance to the food, cosmetics, drugs, and medical device industries.
We bring years of experience serving global clients, combining technical competence, customer orientation, and reliability in regulatory compliance. Our commitment is to keep your confidential information safe and fulfill FDA requirements to maintain a bulletproof compliance plan, allowing you to confidently focus on your core business operations.
FDA Listing Inc. is a New York Corporation founded in 2018 that provides FDA registration and listing, labeling compliance, U.S. agent services, and FDA detention assistance to the food, cosmetics, drugs, and medical device industries.
We bring years of experience serving global clients, combining technical competence, customer orientation, and reliability in regulatory compliance. Our commitment is to keep your confidential information safe and fulfill FDA requirements to maintain a bulletproof compliance plan, allowing you to confidently focus on your core business operations.
Medical Devices
Complying with the FDA’s medical device regulations is crucial for device manufacturers and distributors. At FDA Listing Inc., we are dedicated to helping you meet these standards to guarantee your device’s safety, quality, and regulatory compliance in the U.S. market.
Our expert team offers end-to-end support throughout the medical device compliance process, covering everything from facility and facility and device registrations to UDI requirements and labeling compliance. We ensure your products meet FDA requirements for a seamless entry into the market.
Medical Devices
Complying with the FDA’s medical device regulations is crucial for device manufacturers and distributors. At FDA Listing Inc., we are dedicated to helping you meet these standards to guarantee your device’s safety, quality, and regulatory compliance in the U.S. market.
Our expert team offers end-to-end support throughout the medical device compliance process, covering everything from facility and facility and device registrations to UDI requirements and labeling compliance. We ensure your products meet FDA requirements for a seamless entry into the market.
Kim Oon
We are a company in Malaysia. We export skincare products. A company approached us but with a price that is sky high and they made is sounded like the process is very complex. Thank you to Mr Mohsen for the professional service rendered. will introduce FDA Listing Inc to our government export org for sure. Fantastic Job !
Gamariel
I needed immediately assistance and I had to find a way to register with the FDA. When my company reached out to FDA Listings Inc, Mr. Monsen was ready to ease everything for us. He was very polite, professional. I definitely recommend FDA Listings Inc to anyone who’s conducting business in food, drugs, medical devices, and cosmetic.
Ascentech Solution
We are LED Lights and Medical devices manufacturer and we wanted to register our company with the FDA. FDA listing Inc is our US agent and best service provider, In the whole process we stuck at various points but Mason helps us every time. He helped us without caring the timings difference between India and US. We had a wonderful experience with him.
Pierluigi Folcarelli
For the company I work for, export to the US has always been of critical importance. When I started dealing with FDA-related issues, I sought help online, and I discovered FDA Listing Inc. Worth of mention was Mr. Mason, who assisted and taught me a lot about FDA. I would therefore strongly advise anyone in need for help with FDA, to contact them.
Malka Livingston
Our US company, for MedShield Products, is so grateful to FDA Listing Inc for all their help with our sanitizer OTC listing. They are extremely professional with super speed responses to all our questions. They made the process simple and the personnel is so pleasant to work with. We had the pleasure of working with Mohsan, and he is amazing!
Kim Oon
We are a company in Malaysia. We export skincare products. A company approached us but with a price that is sky high and they made is sounded like the process is very complex. Thank you to Mr Mohsen for the professional service rendered. will introduce FDA Listing Inc to our government export org for sure. Fantastic Job !
Gamariel
I needed immediately assistance and I had to find a way to register with the FDA. When my company reached out to FDA Listings Inc, Mr. Monsen was ready to ease everything for us. He was very polite, professional. I definitely recommend FDA Listings Inc to anyone who’s conducting business in food, drugs, medical devices, and cosmetic.
Ascentech Solution
We are LED Lights and Medical devices manufacturer and we wanted to register our company with the FDA. FDA listing Inc is our US agent and best service provider, In the whole process we stuck at various points but Mason helps us every time. He helped us without caring the timings difference between India and US. We had a wonderful experience with him.
Pierluigi Folcarelli
For the company I work for, export to the US has always been of critical importance. When I started dealing with FDA-related issues, I sought help online, and I discovered FDA Listing Inc. Worth of mention was Mr. Mason, who assisted and taught me a lot about FDA. I would therefore strongly advise anyone in need for help with FDA, to contact them.
Kim Oon
We are a company in Malaysia. We export skincare products. A company approached us but with a price that is sky high and they made is sounded like the process is very complex. Thank you to Mr Mohsen for the professional service rendered. will introduce FDA Listing Inc to our government export org for sure. Fantastic Job !
Gamariel
I needed immediately assistance and I had to find a way to register with the FDA. When my company reached out to FDA Listings Inc, Mr. Monsen was ready to ease everything for us. He was very polite, professional. I definitely recommend FDA Listings Inc to anyone who’s conducting business in food, drugs, medical devices, and cosmetic.
Medical Devices; Who Must Register List and Pay Fee
Establishments that are involved in the production and distribution of medical devices intended for commercial distribution in the U.S., including those that are imported for export only, are required to register annually with the FDA. Most establishments that are required to register are also required to list the devices and the activities performed on those devices at that establishment ...
N95 Respirators 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) and Occupational Safety and Health Administration (OSHA) also regulate N95 respirators ...
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, medical device, drugs and cosmetics. All food facility registrations must be renewed every ‘even year’ between October 1st, and December 31st ...
FDA Regulations for Importing Medical Masks
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 the U.S. that are trying to meet this demand. Below is the summary of FDA regulatory requirements for importing medical mask to the U.S. What are the FDA requirements ...
Medical Devices; Who Must Register List and Pay Fee
Establishments that are involved in the production and distribution of medical devices intended for commercial distribution in the U.S., including those that are imported for export only, are required to register annually with the FDA ...
N95 Respirators 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) ...