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 these phrases mean, and does it mean these products are safe or endorsed by the FDA?

Please 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 public health. The FDA regulates various 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 these products’ safety, efficacy, and security. 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 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 many products, but for 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 are responsible for implementing and enforcing the laws and regulations that apply to radiation-producing electronic products and medical devices, including 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 but oversees the creation of voluntary standards for various manufacturing processes, products, systems, services, and personnel in nearly every U.S. business sector. It also ensures that U.S. standards are consistent with international standards enabling U.S. products to be sold and used abroad.

In addition to 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 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, face masks, and tongue depressors. 47% of medical devices are classified as Class I devices, and most (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 many 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 devices are implanted into the body, life-sustaining, or otherwise present an unreasonable risk. Class III devices include pacemakers, breast implants, and replacement heart valves. These devices must apply for Premarket Approval (PMA). 

 

FDA Registration

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) 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 reviews all the information for a given facility and its associated device listings.

Congress has authorized the FDA to collect device establishments’ annual registration fees. Most establishments required to register with the FDA are also required to list devices made there and activities performed with 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 required 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 industries regulated by the FDA have to register with the FDA to keep a catalog of all 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 from a manufacturer registered with the FDA 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 can monitor the safety of products and devices registered to them through the MedWatch program. 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 Who Are Not FDA Registered

Unfortunately, not all medical devices sold and bought are listed with the FDA. Manufacturers in other countries, for example, may not have registered with the FDA nor listed their devices, let alone gone through any premarket process. This means that marketing and selling 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 ineffective at best or unsafe and cause harm to the user or client at worst. 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 through 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 food additives for use in food for animals.

Human Food Additives. The FDA approves 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 the 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 medical device facilities must register their facilities with the 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 from premarket processes. They require 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: 

  1. Premarket Notification 510 (k) or 
  2. Premarket Approval

Premarket Notification 510(k) for Class II Devices

The manufacturer may submit a 510(k) or Premarket Notification if a medical device is not exempt. There are thousands of medical devices available today, so independently and rigorously testing devices 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 to obtain clearance to market their product for the same purposes granted by the other product, also called the “predicate.”

Medical devices undergoing the Premarket Notification 510(k) process obtain “FDA Clearance.” They’re similar to a predicate in their materials, function, and purpose, and they’re most likely not going to pose a 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, which 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 to be marketed and sold in the U.S.

Note: 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 device manufacturer 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

The manufacturer must obtain an Investigational Device Exemption (IDA) to conduct human clinical trials. This allows the device to be distributed to the facilities listed in the exemption to conduct clinical trials and collect the 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 with 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 Apex, Pinnacle, and Summit Systems as therapeutic devices include:

Class II General & Plastic Surgery Device

The intended use of the Aspen Laser Pinnacle and Summit Systems as a general surgery device is to temporarily increase clear nails in patients with onychomycosis

FDA Product Codes

Aspen Laser products use Product Code IYL (heating lamp) and Product Code PDZ.

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 each FDA 510K Clearance Letter with the indicated 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.

Last updated on July 5, 2022

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