The Difference Between FDA Registered, FDA Approved, and FDA Cleared
We hear a lot about the FDA: in the news, when we’re looking at products in our local pharmacy, at the doctor’s office, and even in the vet’s office. Products from foods to medicines to health monitoring applications tout phrases like “FDA Registered,” “FDA Approved,” and “FDA Cleared.” But what do all of these mean, and does it mean these products are safe or even endorsed by the FDA?
Keep reading to learn the difference between these phrases, what it means to attain them through the FDA, and why FDA regulatory processes are important.
What Does the FDA Do: The Role and Function of the FDA
The FDA, or the Food and Drug Administration, is the government agency in the United States responsible for protecting the public health. The FDA regulates a variety of consumer products, including food, medications, vaccines, medical devices, electronics that emit radiation, cosmetics, veterinary products, and tobacco. For a complete list of what the FDA regulates, see this article.
The responsibility of the FDA is to protect public health by ensuring the safety, efficacy, and security of these products. This means that products are safe to use and benefits outweigh any potential risks, they’re effective for the intended purpose claimed by the manufacturer, and they haven’t been tampered with in order to cause harm (this is why over-the-counter medications have foil seals, for example).
The FDA is responsible for the safety and efficacy of a lot of products, but for the purpose of this article, we’ll focus on how the FDA regulates medical devices.
Additional Regulatory Organizations: CDRH, IEC & ANSI
CDRH – The Center for Devices and Radiological Health
The Center for Devices and Radiological Health (CDRH) is a regulatory bureau within the U.S. Federal Food and Drug Administration (FDA) of the Department of Health and Human Services. They have the responsibility for implementing and enforcing the laws and regulations which apply to radiation- producing electronic products and medical devices that include lasers and light devices.
IEC – The International Electrotechnical Commission
The International Electrotechnical Commission is an international standards organization that prepares and publishes international standards for all electrical, electronic and related technologies – collectively known as “electrotechnology”.
ANSI – The American National Standards Institute
The American National Standards Institute (ANSI) oversees the creation and dissemination of business norms and standards in the United States. ANSI is a private and nonprofit organization that does not develop standards itself, but oversees the creation of voluntary standards for a variety of manufacturing processes, products, systems, services and personnel in nearly every U.S. business sector. It also works to ensure that U.S. standards are consistent with international standards enabling U.S. products to be sold and used abroad.
In addition to its role in promoting standardization, ANSI also works to provide accreditation to organizations that provide certification of products or personnel. ANSI is actively involved in the accreditation programs that oversee those standards, including ISO 9000 (quality) and ISO 13485 (medical devices) management systems.
FDA Classification Levels of Medical Devices: Class I, II, & III
There are three different classifications of medical devices through the FDA, Class I, II, and III. The class a device falls into is determined by the potential risk of using the device, and medical devices include everything from tongue depressors to pacemakers.
Class I medical devices pose minimal risk to the user. They include devices like elastic bandages and tongue depressors. 47% of medical devices are categorized as Class I devices, and most of them (95%) are exempt from regulatory processes. This means most products in this class do not have to undergo any premarket process with the FDA.
Class II medical devices pose a medium risk. This category represents 43% of all devices and includes a wide variety of devices from motorized wheelchairs to some pregnancy test kits to the Apple Watch ECG app. Some Class II devices are exempt from regulatory processes, but most must at least submit a 510(k), or premarket notification.
Class III medical devices pose the most risk to a patient. Only 10% of devices fall into this category. These are devices that are implanted into the body, life sustaining, or otherwise present an unreasonable risk. Class III devices include things like pacemakers, breast implants, and replacement heart valves. These devices must submit an application for Premarket Approval (PMA).
Requirements For Companies
All medical device companies must be registered with the FDA.
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 are required to register annually with the FDA. This process is known as establishment registration. The required annual registration is a review of all the information for a given facility and its associated device listings. Congress has authorized the FDA to collect an annual establishment registration fee for device establishments. Most establishments that are required to register with FDA are also required to list the devices that are made there and the activities that are performed on those devices. Registration and listing provides FDA with the location of medical device establishments and the devices manufactured at those establishments.
Knowing where devices are made increases the nation’s ability to prepare for and respond to public health emergencies.
Requirements for Medical Devices
All medical devices must be registered with the FDA.
Registering a medical device company and its Class I, II or III medical devices is a requirement to market and sell those products in the United States.
Every manufacturer of medical devices, including businesses that re-pack or re-label such devices, must register annually with the FDA and list their products in the FDA’s Registration & Listing database. Most manufacturers of products in the industries regulated by the FDA have to register with the FDA so the FDA can keep a catalog of all the products under their regulation.
Manufacturers of devices exempt from regulatory processes, or generic devices, still have to register their company with the FDA and list their products with the FDA into the appropriate generic category.
A device that is “only” FDA Registered is not necessarily effective for the specific treatment applications claimed by the manufacturer. Registration simply means the FDA is aware of the manufacturer and their devices. The manufacturer cannot claim the device is “FDA Cleared or Approved”, and they cannot use the FDA logo in marketing or labeling the device.
The FDA is able to monitor the safety of products and devices registered to them through a program called MedWatch. Healthcare professionals, patients, and consumers can use MedWatch to report any serious problems they have with a medical device or product.
The Problems With Buying Devices from Companies Not Registered
Unfortunately, not all medical devices that are sold and bought have been listed with the FDA. Manufacturers in other countries, for example, may not have registered with the FDA and listed their devices, let alone gone through any premarket process. This means that the marketing and sale of these devices as medical devices in the U.S. is illegal.
Using a device that hasn’t been listed, cleared, or approved by the FDA as a medical device is extremely dangerous. The device may be unsafe or ineffective and cause harm to the user or client. Additionally, using a device not listed with the FDA means there is no protection for a healthcare or wellness professional should a client have a harmful experience.
If you’re unsure if a medical device is listed with the FDA, you can search for the manufacturer in the Registration & Listing Database.
FDA Approval: What is Really FDA Approved?
The highest-risk devices (Class III), such as mechanical heart valves and implantable infusion pumps, generally require FDA approval of a premarket approval application before marketing.
To receive FDA approval for these devices, manufacturers must demonstrate with sufficient, valid scientific evidence that there is a reasonable assurance that the devices are safe and effective for their intended uses.
What Else Does The FDA Approve?
New Drugs and Biologics. The FDA approves new drugs and biologics.
Animal Drugs & Food Additives. The FDA approves animal drugs and approves food additives for use in food for animals.
Human Food Additives. The FDA approves food additives in food for people.
Human Cells & Tissues. The FDA uses a risk-based approach for human cells and tissues.
What Doesn’t The FDA Approve?
Companies. The FDA doesn’t approve companies. The FDA does not approve health care facilities, laboratories, or manufacturers; however, the FDA does have authority to inspect regulated facilities to verify that they comply with applicable good manufacturing practice regulations. Owners and operators of domestic or foreign food, drug, and most device facilities must register their facilities with FDA, unless an exemption applies.
Compounded Drugs. The FDA doesn’t approve compounded drugs.
Dietary Supplements. The FDA doesn’t approve dietary supplements.
Cosmetics. The FDA does not approve cosmetics.
Medical Foods. The FDA doesn’t approve medical foods.
Misuse of FDA’s logo may violate federal law
The FDA’s logo is for official government use only. The FDA’s logo should not be used to misrepresent the agency or to suggest that FDA endorses any private organization, product, or service.
FDA Clearances: What is FDA Cleared?
Class 1 devices that present a low risk of harm to the user (for example non-powered breast pumps, elastic bandages, tongue depressors, and exam gloves) are subject to general controls only, and most are exempt from premarket notification requirements 510 (k).
Class II devices are not exempt and require that the FDA “clears” all moderate-risk medical devices (for example, dialysis equipment and many types of catheters) for marketing once it has been demonstrated that the device is substantially equivalent to a legally marketed predicate device that does not require premarket approval.
All medical devices must at least be FDA Registered. However, devices that are not generic or otherwise exempt must go through one of two premarket processes:
- Premarket Notification 510 (k) or
- Premarket Approval
Premarket Notification 510(k) for Class II Devices
If a medical device is not exempt, the manufacturer may submit a 510(k) or Premarket Notification. There are thousands of medical devices available today, so independently and rigorously testing devices that are similar to each other would take ages and ultimately slow progress in improving public health.
A 510(k) allows a manufacturer to submit evidence that their device is similar enough to another device that has been through the Premarket Approval process and obtain clearance to market their product for the same purposes granted by the other product, also called the “predicate.”
Medical devices that go through the Premarket Notification 510(k) process obtain “FDA Clearance”. That is, they’re similar to a predicate in their materials, function, and purpose that they’re most likely not going to pose different or increased risk than the predicate device.
FDA Clearance Versus FDA Approved for Class II Non-Exempt Devices
When a non-exempt medical device has FDA Clearance, the manufacturer can market and sell that device in the U.S. However, they may not market their device as “FDA Approved” because it did not go through the Premarket Approval process. They are permitted to market the device as “FDA Cleared,” but the manufacturer cannot use the FDA logo in their marketing or labeling of the device.
Premarket Approval (PMA) for FDA Approval of New and Class III Devices
New medical devices that are not similar in function, materials, design, or purpose to another device on the market, must submit a Premarket Approval (PMA) application to the FDA in order to be marketed and sold in the U.S. It is important to note that most medical devices DO NOT have to go through the Premarket Approval process.
Only new Class III medical devices need PMA approval. These are devices implanted into the body, life-sustaining devices (i.e. pacemakers), or otherwise pose a significant risk to the patient (i.e. PET scanning devices). Other FDA regulated products that need approval are products like prescription drugs, vaccines, and OTC medications.
The PMA process requires the manufacturer of the device to provide valid evidence from human clinical trials that the device is safe to use and effective for the intended purpose.
IDE: Investigational Device Exemption
To conduct human clinical trials, the manufacturer must obtain an Investigational Device Exemption (IDA). This allows the device to be distributed to the facilities listed in the exemption to conduct clinical trials and collect evidence needed for the PMA application.
FDA Approved means that, through this process, the device has shown that the “benefits of the product outweigh the known risks for the intended use.” Manufacturers whose devices have FDA approval may market their devices as “FDA Approved.”
FDA Status: Aspen Laser Therapy Systems
Aspen Laser, LLC is registered with the FDA, and all of our therapy system models are listed as Class II medical devices.
Class II Physical Medicine Therapeutic Device
Intended uses of Aspen Laser Pinnacle and Summit Systems as therapeutic devices include:
- Relaxation of muscles and relief from muscle spasms
- Temporary relief of minor muscle and joint aches, pain and stiffness
- Temporary relief of minor pain and stiffness associated with arthritis
- To temporarily increase blood circulation
Class II General & Plastic Surgery Device
Intended use of the Aspen Laser Pinnacle and Summit Systems as a general surgery device is to temporarily increase clear nail in patients with onychomycosis.
FDA Product Codes
FDA Regulation Numbers
The Regulation Number for Aspen Laser products as Therapeutic Devices is: 21 CFR 890.5500. This number is listed on each FDA 510K Clearance Letter with the FDA indicating the status of this number on the FDA website:
PART 890 — PHYSICAL MEDICINE DEVICES. Subpart F – Physical Medicine Therapeutic Devices. Sec. 890.5500 Infrared lamp.
The Regulation Number for Aspen Laser Products as General & Plastic Surgery Devices is: 21 CF 878.4810. This number is listed on the on each FDA 510K Clearance Letter with the FDA indicated the status of this number on the FDA website:
PART 878 — GENERAL AND PLASTIC SURGERY DEVICES. Subpart E – Surgical Devices. Sec. 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
Learn more about Aspen Laser Therapy Systems through the link below.
This information first appeared on the TheraLight, LLC website and can be found here.