U.S. FDA Medical Device Establishment Registration
An FDA Compliance Attorney is a licensed U.S. lawyer practicing FDA regulatory law.
We can assist manufacturers, remanufacturers, specification developers, re-processors, re-labelers, re-packagers, foreign exporters and initial importers of medical devices that are marketed in the U.S. (“covered parties”) with U.S. Medical Device Establishment Registration and U.S. Agent services.
If you are a foreign or domestic medical device facility seeking to market medical devices in the U.S., you may be required to register and list your establishment and devices with the FDA. Medical device establishment registration and listing is a threshold compliance requirement. Garg Law can assist you in registering your medical device establishment with the U.S. FDA and serving as U.S. Agent (foreign facilities). Our firm can also provide legal and regulatory counsel on navigating medical device establishment registration questions, and other regulatory compliance needs for the successful legal launch of medical devices in the U.S.
What is U.S. FDA Medical Device Establishment Registration?
U.S. regulations require that the owner, operator, or agent in charge of a domestic or foreign medical device establishment, involved in the production and distribution of medical devices intended for use in the U.S., to register annually with the FDA, unless there is an applicable exemption. The definition for “medical device” includes an instrument, apparatus, implement, machine, implant, in vitro reagent or other similar or related article, including a component part of access which is intended for use in the diagnosis of disease, or in the cure mitigation, treatment or prevention of disease in man or other animals.
The regulations require that a medical device establishment renew its registration and listing during the period beginning on October 1 and ending on December 31 of each year. Failure to renew a medical device establishment registration is considered a prohibited act and subject to other enforcement actions.
Registration information should also be updated if there are changes to the marketing or distribution of a device and to the registration.
Who Does it Affect?
The medical device facility registration and listing requirement applies to owners and operators of establishments that are involved in the production and distribution of medical devices intended for use in the U.S. This includes:
- Kit Assemblers
- Contract Manufacturers/Sterilizers
- Specification Developers
- Reporcessors of Single Use Devices
- Complaint Handlers
- Foreign Exporters and Private Label Distributors
- Initial Imports (Initial Distributors)
Which Facilities are Exempt from Medical Device Establishment Registration?
There are a number of operations and facilities that may be exempt from U.S. medical device establishment registration. It is important to have in-house regulatory affairs and/or outside regulatory counsel examine your facility’s operations to determine if your establishment is exempt. We also recommend that you keep a regulatory rationale on file for support.
Generally, the following types of establishments are not required to register.
- Component manufacturers who provide raw materials and/or components used in the manufacture or assembly of a device
- Manufacturers of devices used solely for veterinary purposes
- Retail establishments that provide medical devices directly to end users
- Licensed practitioners, including physicians, dentists and optometrists, who manufacture or otherwise alter devices solely for use in their practice
- Manufacturers whose devices are strictly used in research, teaching or analysis and not introduced into commercial distribution.
When Do I Need to Register my Medical Device Establishment?
Domestic medical device facilities must register their facility within 30 days of putting a device into commercial distribution.
Foreign establishments must register their facility prior to exporting to the United States for the first time.
And initial importers must register prior to importing to the U.S. for the first time. It is important to note that initial importers are only required to register, and are not required to list devices; however, they must identify the manufacturer of each device imported.
If a device requires a premarket submission number (e.g. 510(k)) before being marketed in the U.S., then the owner/operator must also provide the FDA premarket submission number (510(k), De Novo, PMA, PDP, HDE). Unless a waiver has been granted, all registration and listing information must be submitted electronically.
Why is Establishment Registration required?
Medical device facility registration helps provide FDA with the location of medical device establishments and the devices manufactured at those establishments. It provides tracking and tracing of medical device facilities, both foreign and domestic, to increase the ability to more quickly and efficiently respond to public health emergencies.
What happens if I do not register with FDA?
The failure to register a medical device facility is a prohibited act, and may result in enforcement actions, including injunction or prosecution. FDA regulations state that the failure of an establishment to register with the FDA causes the devices manufactured or processed in such an establishment to be misbranded and therefore subject to refusal of admission.
Medical device establishment registration is a threshold requirement for U.S. compliance of medical devices.
Costs for FDA Medical Device Facility Registration
FDA collects an annual establishment registration fee for device establishments. There are unfortunately no waivers or reductions of this fee for small establishments, businesses or other groups. The annual registration user fee for Fiscal Year 2024 is $7,653.
Garg Law provides a service to register foreign and domestic medical device establishments at the following services and fees.
How Garg Law Can Help?
Whether you are a foreign or domestic device establishment, Garg Law can assist you with determining whether your establishment needs to register and list, actually register and list your foreign or domestic medical device establishment with the U.S. FDA, and serve as U.S. agent. With our specific expertise in FDA medical device facility registration, Garg Law can assist you with the following:
- Assist foreign and domestic companies in identifying whether and which facility is required to register and list with the U.S. FDA and whether there are any applicable exemptions.
- Complete U.S. FDA medical device establishment registration for your company including payment of annual registration user fee, electronic submission of registration and listing information, and email notification of completion
- Serve as U.S. Agent for your foreign device establishment
- Make updates to your device establishment registration as needed
- Renew your device establishment registration
- Represent and liaise with the appropriate FDA staff to resolve any medical device establishment registration matters
We have streamlined the medical device facility registration process to more efficiently and quickly respond to business needs. Our step-by-step form and flat fees, which can be found here, allow you to quickly request medical device facility registration. This allows Garg Law to review and complete the registration process for you timely, enabling you and your business to be on its way and one-step closer to U.S. regulatory compliance.
 See 21 CFR Part 807
 See Section 201(h) of the Federal Food, Drug & Cosmetic Act
How to hire an FDA Food Facility Registration Attorney
Setup an initial complimentary consultation with a background on your company, products and US FDA concerns to understand your issues, offer guidance, and how we can further support.
We look forward to hearing from you!