Are you confused about the FDA Approved vs FDA Cleared? These two terms are commonly used when discussing medical products, food, and cosmetics in the United States. However, many people misunderstand their actual meanings. The following article of GOL will help clarify the difference between “FDA Approved” and “FDA Cleared”. Understanding these two terms will help you make informed choices when exporting health and beauty-related products.

What is regulated by the FDA?

Primarily, the Food and Drug Administration oversees the safety and effectiveness of:

• Prescription drugs for humans and animals
• Over-the-counter drugs
• Biologics (such as vaccines, blood products, biotechnology products, and gene therapy)
• Certain dietary supplements (although not all are under FDA regulation)
• Medical devices (ranging from wooden tongue depressors to pacemakers)
• Surgical implants
• Food additives
• Cosmetics
• Products emitting radiation (like X-rays, microwave ovens)
• Tobacco products
• Infant formula

What does it mean if it is FDA approved?

“FDA approved” signifies that the Food and Drug Administration has assessed that the benefits of the product outweigh the known risks for its intended use. To obtain approval, manufacturers are required to submit a premarket approval (PMA) application along with the outcomes of clinical testing.

In the decision-making process for product or drug approval, the FDA evaluates whether the benefits justify the risks. Generally, the FDA may approve a product with higher risks if the potential benefits are substantial, such as an artificial heart valve capable of saving lives.

Read more: How to get FDA approval? Tips for a Successful Application

Which products need FDA approval?

Typically, FDA approval is required to market or sell products in the United States that may pose significant risks of injury or illness but may also have health benefits, such as:

• Prescription drugs
• Over-the-counter drugs
• Vaccines
• Class III medical devices

The FDA classifies medical devices into three categories: III, II, and I.

• Class III: Complex medical devices implanted into the body, sustaining life, or posing a significant risk of injury or illness to the body. Examples include implanted pacemakers, replacement heart valves, and even upgraded breast implants.
• Class II: Devices and products with lower risks and used externally to the body. Examples include condoms, motorized wheelchairs, and urinary catheters.
• Class I: Devices and products with the lowest risks. Examples include medical adhesive tapes and cotton balls.

What does ‘FDA cleared’ signify?

The FDA clears certain types of lower-risk (Class I and Class II) medical devices through a process known as 510(k), which serves as a form of marketing approval. However, most Class I devices are exempt from FDA clearance.

The 510(k) is a premarket notification that medical device companies submit to the FDA to demonstrate that their device is substantially equivalent to another device already on the market, which has been deemed safe and effective for consumer use. Essentially, it must be comparable to a device that does not require premarket approval.

Although most Class I devices are exempt from 510(k) clearance, the majority of devices requiring premarket notification fall under Class II and must adhere to performance standards or Special Controls.

The FDA exempts a majority of Class I devices and certain Class II devices from the 510(k) clearance requirement. These include various categories such as general biological products, diagnostic substances, cardiovascular devices, dental devices, and others.

Premarket notification must be submitted at least 90 days before introducing any device into interstate commerce for commercial distribution.

What is the difference between FDA cleared and FDA approval?

FDA Approved and FDA Cleared are two terms commonly used when talking about medical devices, food, and cosmetics in the United States. However, many people are confused about the real meaning of these two terms.

FDA Approved:

• Applies to:
  • Drugs
  • Class III medical devices (high risk)
  • Some food additives
• Meaning:
  • The product has been thoroughly evaluated by the FDA for both safety and efficacy through clinical trials.
  • FDA confirms that the benefits of the product outweigh the risks.
  • The approval process is rigorous and lengthy.
• Examples: Prescription drugs, heart stents, vaccines.

FDA Cleared:

• Applies to:
  • Class I and II medical devices (low to medium risk)
• Meaning:
  • The product has been evaluated by the FDA for safety and is substantially equivalent to a similar device that was previously FDA Cleared.
  • Does not necessarily have to prove effectiveness.
  • The review process is quicker and less complex than FDA Approved.
• Examples: Bandages, blood pressure monitors, contact lenses.

Summary Table:

Are Food, Cosmetics or Dietary Supplements FDA approved?

• Dietary Supplements: The FDA does not approve for the safety, effectiveness, or labeling of dietary supplements before they are available to the public. It is the responsibility of dietary supplement companies to ensure the safety and accuracy of labeling for their products.
• Food: While the FDA doesn’t provide premarket approval for food products, it does have the authority to approve specific ingredients before their use in food or items intended to come into contact with food, you need to make sure that food mislabeling does not occur. This includes both food additives (substances intentionally added to food or those migrating from food contact products like packaging) and color additives in food.

Companies seeking to introduce new food additives are responsible for presenting the FDA with evidence of their safety. FDA experts scrutinize the results of relevant tests conducted by these companies to ensure the safety of the food additive for its intended purpose. Once approved, a food additive must be used in accordance with its approved uses, specifications, and restrictions.

Some food ingredients, such as those recognized as “generally recognized as safe” (GRAS) for their intended conditions of use by scientific experts, do not necessitate premarket approval from the FDA. The FDA offers a voluntary notification process where a manufacturer can submit evidence supporting the conclusion that the use of an ingredient is GRAS.

• Cosmetic: cosmetic products and ingredients, with the exception of color additives, are not required to be approved by the FDA before they are marketed. However, cosmetics and cosmetic label must comply with regulations to ensure they are not adulterated or misbranded.

 Read more: MoCRA and new FDA regulations for cosmetics

Why does this matter?

The increasing trend of tech companies developing products capable of measuring vital signs and monitoring heart rhythm patterns, once the domain of professional healthcare devices, is significant. With the proliferation of consumer health tech devices, many of them will receive FDA clearance.

Despite the persisting issue of products being cleared based on outdated or unsafe predicates, it’s important not to dismiss devices solely based on that label. The majority of these consumer devices are non-invasive and unlikely to pose significant bodily harm. However, should a day arrive when Apple or another company introduces a Class III device, being informed about the implications will be crucial.

What are the consequences of confusing FDA clearance with approval?

While it may seem like a trivial error, it’s crucial to understand the significance of regulated terminology in ensuring the safety and well-being of patients, healthcare providers, and all users of medical devices.

Misrepresenting terms such as FDA clearance, approval, or granted status on product labels or marketing materials, whether inadvertently or intentionally, can have serious implications. Such misinterpretations can lead to complications for your company, affecting relationships with regulatory authorities and customers alike.

How does the terminology used by the FDA impact regulatory activities?

It’s widely known that FDA inspections encompass Class II and Class III products, with inspectors known for their meticulous attention to detail. Your documentation will undergo thorough scrutiny, making accuracy in even the simplest aspects, such as terminology, crucial.

Imagine an inspector arriving to assess a Class II device and finding it labeled as “approved” on your website. This discrepancy would immediately raise concerns. In such a scenario, the inspector is likely to delve deeper into your processes.

During inspections, perception plays a pivotal role. Starting off with incorrect terminology could set a negative tone. Inspectors often conduct extensive research on companies, including reviewing websites and marketing materials, which are considered part of device labeling. Therefore, it’s vital to ensure that all such information is accurately aligned with your quality management system to avoid potential errors.

Hopefully, this article has helped you gain a clearer understanding of the difference between “FDA Approved” and “FDA Cleared”. Understanding these two terms will assist you in making informed choices when purchasing medical, food, and cosmetic products. Please contact GOL if you have any questions or need further information about FDA-approved or cleared products. We are always available to assist you!

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