US FDA Medical Devices Establishment Registration

Medical devices entering the US market are strictly regulated to ensure patient safety and deliver improved healthcare. The US FDA medical devices establishment registration is an annual process mandated by the U.S. FDA. By implementing mandatory registration, the FDA ensures all medical device establishments abide by the established safety and performance standards. This requirement is vital for FDA to understand the public health preparedness. It acts as an early detection mechanism for issues within the supply chain and provides better oversight. Moreover, it facilitates timely responses in situations, such as recalls or safety alerts. Furthermore, registering your medical device establishment with the US FDA provides uninterrupted access to the U.S. market. Establishment registration is at the core of FDA’s regulatory framework. By registering the establishment, medical device companies can demonstrate regulatory compliance. We will help you easily comply with US FDA medical devices establishment registration and device listing requirements.

What is US FDA Medical Devices Establishment Registration?

US FDA medical devices establishment registration is the process of owners or operators of establishments involved in the production and distribution of medical devices registering with Food and Drug Administration (FDA). These entities involved in the production and distribution of medical devices intended for use in the U.S. must annually register with the FDA prior to selling their devices. As per Title 21 CFR Part 807, US FDA medical devices establishment registration is a mandatory requirement. Notably, registration must be done electronically on the FDA Unified Registration and Listing System (FURLS system). Moreover, annual verification of registration details is a mandatory obligation. The verification can be completed at any time between the 1^st of October and 31st of December each year.

The FDA registration fees have to be paid to complete the registration process. Notably, the fees are subject to periodic revisions and are a significant aspect of compliance for these establishments. Thus, approval from the FDA is necessary in the medical device sector in the USA for operations to commence.

Who needs US FDA medical devices establishment registration?

• Manufacturers: Any entity manufacturing finished medical devices for commercial distribution in the U.S.
• Initial distributors: Entities responsible for first distributing the device domestically.
• Re-packagers and re-labelers: Companies that modify packaging or labeling before distribution of medical device.
• Importers and exporters: Companies importing or exporting medical devices into or out of the U.S.
• Medical device processing: Entities who perform various medical device processing stages, such a sterilization.

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Medical Device Listing Mandate

Registered medical device establishments are required to list the medical devices they manufacture. Organizations must provide information on the devices they manufacture. The premarket submission number, such as US FDA 510(k), premarket approval (PMA), humanitarian device exemption (HDE), etc., has to be furnished, if the device necessitates premarket procedures. Notably, an initial importer must register their establishment but is not required to list the devices. An entity who is responsible for marketing the device entering the US from a foreign manufacturer to the final distributor for sale of the device to the ultimate consumer is considered the “initial importer”.

US FDA Medical Devices Establishment Registration: Exemptions

As per 21 CFR 807.65, certain entities are exempt from the US FDA medical device registration requirements.

• General-purpose laboratory equipment manufacturers (if the device is not labelled or marketed for medical use)
• Manufacturers of raw materials or components used in medical devices (entities who do not directly manufacture the final medical device).
• Veterinary device manufacturers (devices used exclusively for animals).
• Licensed practitioners, such as physicians, dentists, and optometrists, who modify or manufacture devices solely for use in their practice.
• Retail establishments, such as pharmacies, surgical supply outlets, that sell devices directly to consumers.
• Research, teaching, or analysis facilities that manufacture devices only for internal use and do not distribute them commercially.
• Carriers, such as shipping companies, that transport medical devices but do not manufacture or distribute them.
• Dispensers of medical devices, such as hearing aid dispensers, opticians, and hospital personnel, whose primary role is to provide a service rather than manufacture devices.

Notably, certain low-risk devices are exempt from premarket notification (510(k)) requirements. However, manufacturers of these low-risk devices are still required to register their establishments. If you are not sure whether you are exempt from US FDA medical device registration requirements, feel free to reach out to us.

Pharmadocx Consultants: Easily Navigate US FDA Regulatory Requirements

We have extensive knowledge of the US FDA medical device regulatory guidelines. Our team will help you easily navigate the US FDA regulatory requirements, prepare the necessary documents, and submit your application. For any queries or support with US FDA medical devices establishment registration and device listing, drop an email at [email protected] or call/Whatsapp on 9996859227.