- How to register facilities and products, and how to update registrations
- Be wary of products touting FDA certification
- FDA Cleared vs. FDA Approved: What’s the Difference?
- FDA Registered, Cleared, Approved: What’s the Difference?
- How does the FDA ‘approve’ medical products?
- Class 1, 2 and 3
- The 510(k) loophole
- The Myxo ring
- What does the future hold for FDA regulation?
- How to Register with the FDA
- How To Register Medical Devices with the FDA
- How to Register Food/Beverages/Dietary Supplements with the FDA
- How to Register Cosmetic Establishment with FDA:
How to register facilities and products, and how to update registrations
Animal and Veterinary
Domestic and foreign establishments that manufacture, repack, or re-label animal drug products in the United States are required to register with the FDA. Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug products. This process is done in conjunction with the human drug registration process.
- Guidance for Industry – Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing
- Policy & Procedures Manual 1240.3560 – Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
- Step-by-Step Instructions for Creating SPL Files For Electronic Drug Establishment
- Structured Product Labeling
The Voluntary Cosmetic Registration Program (VCRP) is an FDA post-market reporting system for use by manufacturers, packers, and distributors of cosmetic products that are in commercial distribution in the United States.
- Voluntary Cosmetic Registration Program
Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA. Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug products. This information helps the FDA maintain a catalog of all drugs in commercial distribution in the United States.
- Drug Registration and Listing System
Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for consumption in the U.S. are required to register the facility with the FDA.
- Registration of Food Facilities
Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. This process is known as establishment registration.
- Device Registration and Listing
Filing Radiation Safety (Product) Reports for radiation emitting products is required by law. The FDA eSubmitter software replicates several reporting guides and forms. The electronic templates currently available in eSubmitter represent most forms industry is required to submit to FDA.
- eSubmitter: Radiological Health Program
Under section 905 of the Tobacco Control Act, every person who owns or operates any domestic establishments engaged in the manufacture, preparation, compounding, or processing of a regulated tobacco product must register those establishments with FDA by December 31 of each year. All registrants must also submit a list of all tobacco products which are being manufactured by that person for commercial distribution, along with certain accompanying information including all labeling.
- Guidance for Industry: Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments
FDA strongly encourages electronic submission. For electronic submission of such information, FDA utilizes the FDA Unified Registration and Listing System (FURLS)
- Access FURLS
Alternatively, you may use Form FDA 3741 for Establishment Registration and Product Listing. Persons with disabilities having problems accessing the above pdf file may call 1-877-CTP-1373 for assistance.
Vaccines, Blood, Biologics
If you are an establishment that manufactures human cells, tissue, and cellular and tissue-based products (HCT/Ps), FDA regulations require you to register with the agency and list your HCT/Ps. “Manufacture” includes any or all steps involved in the recovery, processing, storage, labeling, packaging or distribution of HCT/Ps, and the screening or testing of the cell or tissue donor. See below for information on how to register with FDA:
- Tissue Establishment Registration
- Human Cell and Tissue Estableshment Registration (HCTERS) Public Query Application
FDA regulations require all blood establishments that collect, manufacture, prepare, store under controlled conditions for further distribution or process blood and blood products to register. See below for detailed information on blood establishment registration:
- Instructions for Completing the Electronic Blood Establishment Registration (BER) and Product Listing Form
Domestic and foreign establishments that manufacture, repack, or re-label drug and biologic products, including vaccines, are required to register with the FDA. Domestic and foreign drug and biologics manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug and biologic products. This information helps the FDA maintain a catalog of all drugs and biologics in commercial distribution in the United States.
- Drug Registration and Listing System
- Drug Firm Annual Registration Status
Be wary of products touting FDA certification
If you’re shopping for a pill or gadget to trim your waistline, grow your hair or generally make you feel better, you probably take comfort in the words “FDA approved” or “FDA registered.”
Even in a time of widespread distrust of government, most people continue to put their faith in the Food and Drug Administration, says Daniel Carpenter, professor of government at Harvard University and author of the soon-to-be published book “Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA.”
“FDA approval is like the Good Housekeeping seal of approval, only much more so,” Carpenter says. “Sellers try to take advantage of that reputation.”
But as reassuring as they may seem, the words “FDA approved” or “FDA registered” don’t mean as much as consumers often assume. “FDA certification of a product is never a guarantee of safety or effectiveness of anything,” Carpenter says.
The long list of products flaunting their FDA bona fides includes the Flex Belt, the HairMax laser comb and a supplement called Canditate. The Flex Belt, an electronic exercise device that stimulates the abdominal muscles, is described online as the “only ab belt toning system cleared by the FDA for toning, firming and strengthening stomach muscles.” The website for HairMax says the product has “FDA clearance,” an honor that supposedly represents “a milestone in hair care, hair growth and hair science.” A site touting Canditate, a remedy for yeast infections, calls it “an FDA-approved herbal product.”
All products that make health-related claims need some kind of clearance by the FDA. Cosmetics don’t – unless they claim to treat specific problems such as dandruff or acne. Consumers trying to sort out marketing claims should understand that the FDA holds different products to different standards, says Dr. William Maisel, an assistant professor of medicine at Harvard Medical School and the director of the Medical Device Safety Institute at Beth Israel Deaconess Medical Center in Boston.
Strictly speaking, he says, the only products that the FDA actually “approves” are drugs and serious high-tech medical devices such as implantable defibrillators. Other products may be “listed” or “registered” with the agency, but that’s a big step down from actual approval; determining whether any particular product has actually gone through the right channels can be difficult.
It’s important to realize that the FDA doesn’t regulate vitamins, herbs or other dietary supplements. “If a company claims that a supplement is FDA approved, you should doubt that altogether,” Carpenter says. Some companies openly flout that law, but the FDA has limited resources to stop offenders, he says.
A few herbs really do have approval, but only as an ingredient in FDA-approved drugs. For example, yohimbine, a compound derived from the herb yohimbe, is FDA approved for the treatment of male sexual dysfunction.
Because the FDA doesn’t test supplements, companies aren’t allowed to claim that their vitamins or herbs can treat or prevent any specific disease, which is why so many products claim to simply “promote” health. “They don’t have to come to us to have that claim evaluated,” says Dr. Robert Temple, director of the Office of Medical Policy at the FDA’s Center for Drug Evaluation and Research. “It can usually be assumed that they don’t have good evidence for it.”
Prescription drugs, in contrast, have to go through a rigorous testing process to convince the agency that the product has some benefits that outweigh the risks. Over-the-counter drugs, such as cough syrups and pain relievers, are also monitored by the FDA, although the testing process isn’t as rigorous, especially if the product is considered likely to be safe.
The agency takes a similar hard-line approach to serious medical devices such as implantable defibrillators. Like drugs, these devices — also called Class 3 devices — are supposed to go through serious testing to establish both safety and effectiveness.
For less-invasive medical equipment, known as Class 2 medical devices, the standards and the scrutiny drop dramatically. This category includes some hospital devices, such as X-ray machines, along with consumer products such as powered wheelchairs and skin lasers.
Exercise equipment can fall into the Class 2 category if the company claims to do something other than promote general fitness, such as rehabilitating injured joints or speeding weight loss. Before they can sell such products, manufacturers have to convince the FDA that devices are “substantially equivalent” to similar products already on the market, regardless of whether those existing products actually work. Passing this test gives them FDA “clearance,” but not approval.
In some cases, companies claim to follow in the footsteps of existing products that seem very different from their own. In their application to the FDA, manufacturers of the HairMax laser comb claimed to be on the same level as a laser device intended to kill lice.
Manufacturers of Class 1 devices — gadgets with few or no moving parts, such as tongue depressors, usually have to simply register with the FDA. When the agency allows such devices to go to market, “they aren’t passing judgment that one tongue depressor is any better than any other tongue depressor,” Maisel says. “They’re just saying it’s a safe device.”
In recent years, experts both within and outside the FDA have expressed concern that the agency has been too quick to approve some devices. The head of the FDA’s Center for Devices and Radiological Health resigned last August after the agency approved a nerve stimulator and a device for knee surgeries despite the objections of FDA scientists. “Things were getting through that were not sufficiently tested,” Carpenter says.
The FDA recently asked the Institute of Medicine to review the agency’s approach to approving medical devices. The final report is scheduled to come out in spring 2011. The Institute of Medicine declined to comment on its findings so far.
FDA Cleared vs. FDA Approved: What’s the Difference?
Many people have asked us why we’re just FDA Cleared, and what the different between Cleared and Approved is. The difference actually has nothing to do with quality, nor is FDA Approved better than FDA Cleared. Here’s how it works:
The FDA separates the items under its purview into three groups, which it calls Class I, Class II and Class III. An item’s product type determines which Class something is, and which Class something is determines whether it is Approved, Cleared, or Registered.
|Class I||Registered||Toothbrushes, elastic bandages, enema kits||93% are exempt from pre-market review.|
|Class II||Cleared||Wheelchairs, some pregnancy tests, Aulisa’s Guardian Angel||FDA review through premarket notification (510(k)|
|Class III||Approved||Implantable pacemakers, breast implants. Medicines also require FDA “Approved”.||FDA review through premarket approval (PMA) or humanitarian device exemption (HDE)|
That means your toothbrush is FDA Registered because it is the type of classification given to toothbrushes by the FDA, not because you have a sub-standard toothbrush. Similarly, our Guardian AngelTM Rx* line of products is FDA Cleared because that’s what our type of product is given by the FDA.
*Guardian AngelTM for in-home use applies the same FDA Cleared technology used in our Rx line of products.
FDA Registered, Cleared, Approved: What’s the Difference?
If a company wants to sell a medical device, it needs to let the FDA know about the device. How much and what type of information must be shared with the FDA, however, depends on the potential risks to users (and/or patients).
The FDA puts medical devices into three different buckets, creatively listed as Class I (low risk — think bedpans), Class II (higher risk — think exercise equipment and pregnancy test kits), and Class III (highest risk — think pacemakers). What classification bucket the medical device falls into will determine the applicable FDA “label” for the product — from FDA registered or listed, to FDA cleared and FDA approved. Which is to say, it is primarily a measure of risk that decides how a device ends up marketed as FDA listed or FDA approved or somewhere in-between.
Here’s a breakdown of the different classes:
- Class I products: Forty-seven percent of medical devices fall into this category. Class I devices are generally not subject to any premarket review by the FDA but still must register with the FDA. These products are sometimes marketed as “FDA registered” or “FDA listed,” but that’s like saying you’re on a guest list for entry into a nightclub that pretty much everyone gets into.
- Class II products: A slightly smaller percentage of medical devices, 43 percent, fall into this category. Before a Class II product can be sold it must show the FDA that it is “substantially equivalent” to another product that the FDA has already given clearance. The reasoning goes that if it’s pretty similar to another “cleared” product then it’s as safe and effective as the other device. Imagine the review process for Class II devices as a giant game of dominoes where every new product needs to match up to one that is already on the table. It’s not that hard to do, though that did not stop one marketer from citing FDA clearance in support of claims that its Class II laser therapy caps have no side effects and are clinically proven to regrow hair (claims that the marketer would be forced to discontinue). Because it’s not that rigorous a review standard, when you see something marketed as “FDA cleared,” it’s sort of like someone saying, “I’m good at dominoes” — it’s just not that impressive.
- Class III products: Class III devices, on the other hand, must be impressive in order to be sold to consumers. Class III products (about 10 percent of all medical devices) are subject to a rigorous review process by the FDA, and are eventually known as “FDA approved” devices. These devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury.
See our related ad alerts here: Capillus laser hats, Lo-Bak TRAX.
How does the FDA ‘approve’ medical products?
You may have seen medical products that claim to be “FDA cleared,” “FDA registered,” “FDA listed” or “FDA approved” – but what do these labels mean? You would be forgiven for feeling confused.
In this feature, we look at what the differences in Food and Drug Administration (FDA) classification actually mean, what you need to be aware of as a consumer and what the future holds for the regulation and classification of medical products in the US.
Though you may see labels on a wide variety of medical products – from implantable defibrillators to smartphone apps – bearing legends such as “FDA registered,” in reality these claims are often disingenuous. But regulation over the correct terminology is rarely enforced.
Class 1, 2 and 3
In truth, the only products that the FDA specifically “approve” are drugs and life-threatening or life-sustaining “Class 3” medical technology (such as defibrillators). These are submitted to a rigorous review process called “pre-market approval” (PMA), to prove that the benefits of the products outweigh any potential risks to the health of the patient.
Share on PinterestThe only products that the FDA specifically “approve” are drugs and life-threatening or life-sustaining “Class 3” medical technology.
Scientific evidence from clinical trials must be provided by the manufacturers demonstrating the safety and effectiveness of their product. Just 1% of products pass PMA.
Over-the-counter drugs are monitored by the FDA, but they are submitted to a less rigorous testing procedure, especially if they are assumed to be safe.
Vitamins, herbs and supplements are not tested by the FDA unless they are an active ingredient in a drug that requires FDA approval – so manufacturers of supplements are not allowed to claim that their products can treat any specific disease, only that they “promote health.”
Despite this, some supplement companies are known to illegally claim their supplements are “FDA approved.” It is thought that the FDA are unable to intervene in every instance due to limited resources.
Low-risk medical devices, such as stethoscopes and gauze, are known as “Class 1” and are exempt from FDA review.
“Class 2” medical devices are defined as not life-sustaining or life-threatening, though this category covers a wide spectrum of devices, from X-ray machines to some exercise equipment.
The level of scrutiny attached to Class 2 devices is much lower than Class 3. The devices do need FDA “clearance” before they can be marketed and sold, but rather than submit their products for clinical trial, the manufacturers are required instead to convince the FDA that their products are “substantially equivalent” to products that have been previously cleared by the FDA.
Substantially equivalent means that the device has the same intended use and approximate technical characteristics as an existing product.
Products that pass this clearance process may be referred to as “FDA cleared” or “FDA listed,” but this is not the same as “FDA approved,” which only relates to the prescription drugs and Class 3 devices that have passed PMA.
This approval method for Class 2 devices has been the subject of mounting controversy. The process is known as “510(k)” – named after its section in the law.
The 510(k) loophole
Although the FDA requests clinical data in about 10% of cases, one concern over the 510(k) system is that testing is insufficient and so products that are either unsafe or ineffective could be released to market.
Share on PinterestUnder 510(k), devices that have passed clearance, but have later been found dangerous or ineffective and are recalled, are not automatically removed from the FDA’s list of cleared products.
Another worry about this process is that the more “substantially equivalent” (but not identical) products are listed, the more a chain grows of FDA-cleared products that increasingly move away from the original product.
But perhaps the most concerning feature of 510(k) is that devices that have passed clearance, but then have later been found dangerous or ineffective and are recalled, are not automatically removed from the FDA’s list of cleared products.
This is a loophole that allows any new products bearing the same faults to remain eligible for FDA clearance through 510(k).
In a 2012 report, the Institute of Medicine (IOM) recommended that 510(k) be replaced with an “integrated pre-market and post-market regulatory framework that effectively provides a reasonable assurance of safety and effectiveness throughout the device life cycle.”
But these recommendations – though popular with consumer advocacy groups – were rejected by the FDA.
A congressman (now senator) for Massachusetts, Ed Markey, campaigned for the reform of 510(k) and proposed a 2012 bill to close the loophole.
But the bill was not passed. It received opposition from medical device manufacturers and members of Congress who claimed that the existing FDA review processes are already too time-consuming and unpredictable, compared with other countries, so inserting more safeguards and regulatory steps would have the effect of strangling innovation.
Medical News Today spoke to Dr. Michael A. Carome, director of the non-profit consumer rights organization Public Citizen’s Health Research Group, about 510(k).
Dr. Carome cites a report that Public Citizen issued in 2012 highlighting “a concerted lobbying campaign intended to weaken the already lax regulatory oversight of medical devices.”
“For example, in 2011 the medical device industry spent $33.3 million on lobbying, raising its total to $158.7 million since 2007. This lobbying campaign has been very successful and has generally drowned out calls for stronger medical device regulation from consumer advocates like Public Citizen.”
Carome also sees a second obstacle in the FDA itself, “which has been very resistant to proposals to strengthen or replace the 510(k) system.”
“The FDA seems beholden to the medical device industry and the mantra that promotion of ‘innovation’ is the most important goal in the regulation of medical devices,” he adds.
More recently, Sen. Markey wrote to the FDA, appealing directly for them to reform 510(k).
Sen. Markey was satisfied with the FDA’s response, announcing in December 2013 that database modifications proposed by the agency “will help decrease the dangers and increase the awareness of medical devices that may be made based on flawed models.”
Dr. Carome feels, though, that the FDA’s proposed measures “fail to adequately address the underlying flaws in the 510(k) premarket clearance process.”
The central issue remains that new Class 2 medical devices found to be “substantially equivalent” to recalled but previously cleared devices are still obliged – by law – to be cleared by the FDA, despite whatever flaws the devices contain.
“The slightly improved transparency provided by FDA’s revised database for 510(k)-cleared devices does not close this dangerous loophole in the existing law that threatens patient safety,” Carome concludes.
But what are the Class 2 devices that have caused patient safety concerns?
Carome points to the DePuy metal-on-metal Articular Surface Replacement (ASR) hip implant – an “example of a medical device heavily promoted as being innovative and better than earlier types of devices.”
In November 2013, DePuy – an orthopedics company owned by Johnson & Johnson – announced a $2.5 billion settlement to resolve more than 8,000 of 12,000 public liability claims filed in US courts after their metal-on-metal hip was recalled in 2010. The ASR was found to shed metallic debris as it wears, causing pain and injury to the patient.
The Myxo ring
In 2008, a surgeon named Dr. Patrick McCarthy at Chicago’s prestigious academic medical center, Northwestern Memorial Hospital, was found to be installing a device he had invented – the McCarthy Annuloplasty Ring – into the hearts of cardiology patients without the informed consent of the patients.
Share on Pinterest”If you are planning to receive a medical device in a US hospital, there is no way to confirm whether the device is FDA approved, investigational or registered,” says Dr. Rajamannan.
Concerned patients were even more alarmed when they discovered that the ring had also not been submitted to the FDA for review.
“There are no guideposts for us. You don’t learn about this stuff in med school,” McCarthy was quoted by the Chicago Tribune as saying, when questioned on why he had bypassed FDA approval.
The ring’s manufacturer, a company called Edwards Lifesciences, later falsely claimed that the device was exempt from the 510(k) process and so did not require FDA clearance.
When a concerned colleague of McCarthy’s, Dr. Nalini Rajamannan, contacted the FDA, an investigation was triggered, which ultimately saw the ring cleared for use – despite having already been sewn into the hearts of 667 patients.
But further controversy surrounded the FDA’s clearance, which simply relied on a clinical study Dr. McCarthy himself had written as evidence that the ring – now rebranded “Myxo dETlogix” – was safe and effective.
Dr. Rajamannan – who was co-author on that study before withdrawing when she learned that the patients involved were not giving informed consent – later wrote a book detailing the controversy and continues to campaign on behalf of patients installed with the Myxo ring.
Speaking to Medical News Today, she says that the concerns over the Myxo device have still not been addressed by the FDA:
“The FDA has written a formal letter stating that they would not be investigating the matter any further. These heart valve rings that are being cleared under the 510k process for Edwards Lifesciences are associated with over 4,000 adverse events and over 645 deaths.”
“The other major heart valve manufacturers have less than 20 events for their rings in the FDA database.”
What does the future hold for FDA regulation?
As we have shown in this feature, the confusion over the various stages of FDA “approval” and “clearance” is not limited to patients. These examples show that FDA classifications and processes can also – naively or wilfully – be misinterpreted by manufacturers and medical professionals.
The concerns from doctors, patients and consumer advocacy groups on the lack of regulation of medical products and the conflicts of interest within those regulatory processes remain.
Dr. Carome recommends that the IOM’s 2012 guidelines be implemented and suggests that more of the Class 2 products sped through to market under 510(k) need to be reclassified as Class 3, for which the PMA process is much more stringent.
“Manufacturers do heavily promote their devices as being new and innovative, and many health care providers and patients believe that a ‘newer’ or ‘innovative’ device must be better,” reasons Carome. “However, in most cases, there is no evidence that the newer medical devices are any better than older devices or other less-invasive treatments that don’t involve a medical device.”
“It is a real safety problem,” agrees Dr. Rajamannan, who adds: “If you are planning to receive a medical device in a US hospital, there is no way to confirm whether the device is FDA approved, investigational or registered.”
“The patients in the US are at major risk and the FDA is doing nothing to help the patients.”
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 are an owner or operator of a cosmetic manufacturing or packaging facility, you do not need to register your establishment or file product formulations with the FDA. However, the FDA does encourage participation in a Voluntary Cosmetic Registration Program (VCRP) If you choose to participate in the VCRP, you can either
- register your establishment using the Form FDA 2511 or
- file a Cosmetic Product Ingredient Statement using the Form FDA 2512),
- or both
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.