Navigating Registration and Listing for FDA Regulated Products including Medical Products

What is FDA Registration and Listing?

The Agency regulates a wide range of products. However, their legal mandate and subsequent regulations range from the most comprehensively regulated (e.g.: medical devices and pharmaceuticals) to the least regulated (e.g.: cosmetics). The requirement for manufacturers to register their facilities and to list the products being imported or sold in the US also varies widely. How far the registration process goes to include significant service providers to the manufacturer is also different (e.g.: medical devices/pharmaceutical manufacturers have the most extensive network of service providers that must register). For example, medical device registration requirements extend to repackagers, relabelers, sterilization providers, and specification developers. This helps the FDA keep track of medical products being marketed in the U.S. and ensures that they meet the necessary regulatory requirements.

Another significant difference within each of these regulated product groups is the cost of registration. The table below summarizes product areas and the current 2024 fees with the new 2025 fee structure. These fees are limited to registration of facilities and listing of the product (not the clearance or approval submission fees). Pay close attention as to whether FDA charges for registration. A common misperception, which is promoted by some of our competitors, is that food and dietary supplement manufacturers must pay a fee to FDA to register. This is not accurate!!

(1) an active pharmaceutical ingredient (API) facility fee; (2) finished dosage form (FDF) facility fee; and (3) Contract Manufacturing Organization (CMO) facility fee.

The Registration Process

Whether you are registering your establishment for the first time, reregistering for the new year, or reactivation your dormant establishment with the FDA, the process requires that you pay the establishment fee (initial or annual) first. This payment must be paid and processed with the FDA before an establishment can complete the new registration process, or update their existing establishment account. Be aware that to complete the registration process you must update your establishment registration account by providing the payment confirmation numbers for the coming year.

The next step is to verify that your Facility, Owner/Operator, and Official Correspondent information is complete. Once this is accomplished, your Device Listings can be updated to add or remove the product(s) the establishment is selling.

If your establishment is registering for the first time, it takes a bit longer for the FDA to process your information and device listings within their system. Then the FDA will provide the individual FDA Registration Number for your establishment.

If your establishment is outside of the US, as your US Agent, RQMIS, Inc. will support your registration, re-registration, or reactivation on your behalf.

Key Considerations

• Electronic Registration: The FDA requires all Registrations and Listings to be submitted electronically through the FDA
• Annual Fees: There are fees associated with the registration process for certain FDA regulated products, which must be paid annually.
• Compliance with Regulations: Ensuring that your product(s) comply with applicable FDA regulations, including Good Manufacturing Practices (GMP), is crucial for a successful Registration and Listing process.
• Timely Updates: If there are changes to your establishment or products, you must update your Registration and Listing information promptly.

Benefits of Proper Registration and Listing

1. Market Access: Proper Registration and Listing(s) are essential for legal marketing of medical product in the U.S.
2. Regulatory Compliance: Staying compliant with FDA regulations helps avoid legal and financial penalties.
3. Credibility: Registration and Listing enhance the credibility and trustworthiness of your product(s) among healthcare providers and patients

Have RQMIS Help You

The FDA Registration and Listing process can be complex and time-consuming. If you register or classify your product incorrectly it can either cause unnecessary attention by the regulatory bodies or potential compliance action from the same entities, for not classifying your product correctly and not complying with the additional requirements named in the law. At RQMIS, we specialize in guiding companies through the regulatory process, ensuring that your products meet all FDA requirements efficiently and effectively. Our expertise in regulatory affairs, quality management, and clinical study design/management ensures that your medical devices are well-positioned for success within the U.S. market. Other companies focus on registration and listing, but have no real depth of understanding of the medical product classification/approval process and post market compliance. RQMIS has both. Our deep understanding of the regulations assures that your product does not get “over regulated” by improperly classifying and listing your product with the Agency.

Whether you are a startup entering the market for the first time or an established company looking to streamline your compliance processes, RQMIS is here to support you every step of the way. Contact us today to learn more about how we can assist with your FDA Registration and Listing needs.