How to Register with the FDA
Lisa Capote is an FDA lawyer in Florida. She helps clients register their products with the FDA.
The U.S. FDA (United States Food & Drug Administration) requires facilities that manufacture, process, pack or store foods, drugs, and medical devices marketed in the U.S. to file registrations with the FDA. In addition, manufacturers of drugs and devices must list their products with FDA. These registrations and listings must be completed annually to stay in compliance with FDA regulations.
Especially if you are new to the U.S. market, the amount of regulations and oversight can be very confusing. It’s far easier to be compliant from the outset rather than trying to fix mistakes after they have already happened. We provide guidance on the required formats, elements, and details of submissions for FDA registration, such as whether any registration exclusions are applicable. We will help you prepare and submit your registrations to the FDA and track updates, changes, and cancellations to help you meet full compliance. This may involve determining whether any user fees are necessary for registration and assuring that you have proper Issuance of Certificates of Registration. These certificates can help to protect your information and give confidence to U.S. customers that you have received your necessary registration.
Under the Bioterrorism Act, foreign drug and device manufacturers are required to provide to the identity of known US importers. On importation statement must be filed with FDA identifying the registration numbers of various companies in the supply chain. We assist with filing Prior Notices and will work closely with your Customs broker to ensure compliance with Bioterrorism and Prior Notice. We will also act as U.S. agent for foreign facilities.
We understand the complexity of FDA registration and compliance. We are committed to meeting the needs of distributors and manufacturers of a wide range of products, including medical devices, cosmetics, drugs, dietary supplements, and foods with regulatory consulting services. Whether you need assistance with getting the necessary licensure and certifications as a foreign manufacturer of you’d like an extra set of eyes to review your labels and literature for compliance concerns, our legal advice can be paramount in streamlining your business and catching possible issues early on.
Our knowledge of navigating regulatory and compliance issues can help you get to market faster by decreasing the chances that you are derailed by U.S. administrators. When you have worked hard to develop a product, you want to ensure that your product is available to the public as soon as possible. Contact our offices today for a personalized approach to your regulatory and compliance concerns.
How To Register Medical Devices with the FDA
If you are a manufacturer or initial distributor/importer of medical devices, you are required to register your establishment with the FDA.
To initiate the registration process, you need to
- pay the annual registration fee online at the Device Facility User Fee (DFUF) website
- For FY 2016, the annual registration fee was $3,845
- User fee projection for FY 2017 is $3,872
- registration must be verified between October 1st and December 31st of each year
- Log on to FURLS (FDA Unified Registration and Listing System) to register and list your information. An owner or operator must have an account ID and password to access FURLS. If you do not have a FURLS account, you will need to create one.
At the Capote Law Firm, we can assist you with every phase of the FDA Establishment Registration process — which is explained in further detail on the FDA website here.
Medical Device FDA Product Listing
In addition to registering your medical device establishment, you must also list the devices you make and describe the activities that are performed on those devices.
Facilities required to list their devices are those that:
- repackage and relabel,
- develop specifications,
- reprocess single-use devices,
- manufacture accessories and components sold directly to the end user
Medical Device Classifications
The FDA categorizes medical devices by class – Class I, Class II, and Class III for the purpose of defining the risks associated with each device and the regulatory controls needed to ensure their safety and effectiveness. The class your medical device belongs to determines the pre-market process needed to receive clearance or approval to market your device.
The FDA attorneys at the Capote Law Firm will make sure you are complying with the following regulatory requirements set forth by the FDA’s Center for Devices and Radiological Health (CDRH)
- Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA),
- Establishment registration on form FDA-2891,
- Medical Device Listing on form FDA-2892,
- Quality System (QS) regulation,
- Labeling requirements, and
- Medical Device Reporting (MDR)
Class I (elastic bandages, examination gloves, hand-held surgical instruments)
- considered to have low risk of harm to user with least amount of regulatory controls
- exempt from the Premarket Notification or 510(K)
- must follow general FDA policy of registering the medical device and adhere to proper branding and labeling and proper manufacturing techniques; must notify FDA prior to marketing the device
Class II Medical Devices (X-ray machines, powered wheelchairs, infusion pump and surgical and acupuncture needles)
- considered to be intermediate risk devices
- subject to an FDA Pre-Market Notification (PMN) or FDA 510(k) submission and review process
- The PMN or 510(k) process involves submitting evidence to the FDA proving that your medical device is equivalent to a predicate device or device that has been previously marketed legally
- must follow general policy and special labeling, mandatory performance standards and post market surveillance
Class III (implantable pacemaker, pulse generators, HIV diagnostic tests, automated external defibrillators)
- devices which pose a significant risk of illness or injury
- must follow Class I and Class II guidelines but also must go through the FDA Pre-Market Approval (PMA) process
- must also be pre-market approved by the FDA and a scientific review of the medical device must be made prior to marketing
How to Register Food/Beverages/Dietary Supplements with the FDA
All food establishments (domestic and foreign) that manufactures, processes, packs or holds food for consumption by humans or animals in the U.S., must register their company with the FDA. Registration renewals with the FDA must be completed every other year between October 1 to December 31.
Examples of “foods” that may be produced in a facility required to register include but are not limited to:
- raw agricultural commodities (fruit, vegetables, nuts),
- beverages including alcoholic beverages and bottled water
- dairy products and eggs
- dietary supplements and ingredients
- pet food, animal feed
- infant formula
- bakery goods
- snack foods
Each food facility is required to have its own registration number. If you own or operate multiple facilities, you may be required to register and obtain different food facility registration numbers. If your product is moved to another facility, the second facility may also be required to register.
According to the Food Safety and Modernization Act (FSMA), foreign facilities must provide the FDA with the name and contact info of a designated U.S. agent. These agents will serve as communications liaison between the food facility and the FDA.
They must be available 24/7 and willing to work with the FDA to schedule mandatory inspections of the facility. During these inspections the FDA will check to see that you registered correctly, are implementing good manufacturing practices, and complying with labeling
Registering your food establishment may seem simple but the slightest mistake can have significant ramifications for your business. Capote Law Firm
What Happens If I Don’t Register?
Failure to register is a prohibited act under the U.S. Federal Food, Drug & Cosmetic Act and can incur the following consequences
- the federal government can bring civil and criminal charges against you
- your shipment will not be allowed into the United States; your product will be held at the port of entry, and you will be fully responsible for arranging and paying for all storage, transportation and posting of bond.
How to Register Cosmetic Establishment with FDA:
If you choose to participate in the VCRP, you can either
Capote Law Firm can help you navigate the VCRP’s online system. And even though cosmetics are not subject to FDA premarket approval, they are still regulated by laws, namely the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act.
As a manufacturer, you may use any ingredient in the formulation of a cosmetic, provided that
- the ingredient and finished product are considered safe under labeled or customary conditions of use;
- the product is properly labeled, and;
- the ingredient does not cause the cosmetic to be adulterated or misbranded
Our FDA attorneys can work with you to ensure that your products and ingredients are safe, properly labeled, and in full compliance with the law.