FDA’s approach to granting marketing approval to the products it regulates varies widely. Each product, and in some cases, product class, has its own processes and requirements to be labeled FDA cleared vs approved.  

Some products, such as drugs and high-risk medical devices, go through strict testing and reviews before they can be sold in the United States. Others must pass safety requirements for human consumption, performance standards, or closely resemble other products on the current market. Many products don’t need any prior approval or clearance. 

In this article, you will learn some of the differences between different FDA approval processes and how they apply to different regulated products. 

FDA Cleared vs Approved 

FDA approves products based on the relative risk they pose to consumers. Both FDA Clearance and FDA Approval indicate that the product is considered safe and effective for distribution on the U.S. market.  

The more complex a product is and the higher its potential risk for human or animal use, the more testing and review it requires before approval.

Overall, FDA approval has a much stricter set of processes designed to safeguard consumers and determine how safe and effective a product is. FDA experts review products’ safety, quality, and effectiveness before giving approval.  

FDA bases clearance status on previous approvals of similar products or devices or gives it to products considered much lower risk. There are also many products that don’t require clearance by FDA. 

Even after products are approved or cleared, companies must continue to comply with FDA regulations and take corrective action if safety issues arise. 

The processes for FDA Cleared vs Approved status vary based on the type of product and how it’s classified. FDA Approval status specifically refers to certain types of drugs and medical devices, with a few exceptions. Only lower-risk medical devices (Class I and Class II) are cleared by FDA, if they are not considered exempt by the Federal Food, Drug, and Cosmetic Act (FD&C Act). 

What Does FDA Approve? 

Here are some examples of healthcare products that FDA has to approve before they are sold on the U.S. market: 

• New drugs: Drugs new to the market that may contain new chemical formulas or established formulas prescribed for different uses that have not been declared safe and effective 
• Human biologics: Biological products such as proteins, vaccines, and allergenic products, human cells, tissues, and cell and tissue-based products (HCT/Ps) 
• Highest-risk medical devices: Complex devices that are of very high risk to users, such as pacemakers and defibrillators 
• Food and color additives: Natural and synthetic substances added to food, drugs, cosmetics, and medical devices that can be harmful to humans 

 FDA does not currently approve: 

• Food or beverages 
• Facilities, providers, or laboratories 
• Compounded drugs 
• Cosmetics 
• Medical foods or dietary supplements 

To learn more about products that FDA approves across the industries it regulates, read our guide to FDA approval. 

FDA recommends companies become familiar with the guidances and develop a transition plan that addresses the steps that must be taken if they wish to continue marketing their devices in the U.S.  

FDA Approval for Drugs  

FDA approves newly developed and prescribed brand name and generic drugs through the Center for Drug Evaluation and Research (CDER). Drug companies send CDER data from multiple clinical trials to prove the product is safe and effective for its intended use. FDA experts then closely review data along with the drug’s proposed labeling.  

FDA approves the drugs by analyzing factors such as: 

• Target condition and treatments: Reviewers analyze the illness or condition the new drug aims to treat as well as current treatment options on the market. This helps them weigh the risks and benefits of consumer use. 
• Clinical data: FDA checks drug companies’ clinical data to determine how safe it is for human use, assesses clinical benefits and risks, and compares data from trials to verify results. In some cases, companies may only have to submit data from one clinical trial, especially if the disease is rare. 
• Risk management strategies: Reviewers determine how drug companies can best communicate known and potential risks of the drug once it’s on the market. This may include labeling that clearly states risks and information on detecting and managing risks or creating and implementing a Risk Evaluation and Mitigation Strategy (REMS). 

A drug has to have enough benefits to outweigh known or potential risks for its target patients to get FDA approval.

FDA Approval for Medical Devices 

Medical devices fall into three categories: 

• Class I: Devices that are considered low risk for human use and have the lowest potential for harm, such as tongue depressors, toothbrushes, and bandages. They make up the largest portion of all medical devices. 
• Class II: Devices considered to be of moderate to high risk to humans, including pregnancy test kits, syringes, and powered wheelchairs.  
• Class III: Devices that present high potential risk or harm to users, such as breast implants, pacemakers, and defibrillators. They make up the smallest portion of all medical devices, around 10%. 

FDA requires a premarket approval (PMA) application for Class III devices, which are designed to support or sustain human life and represent the most potential risk. PMA is FDA’s most rigorous regulatory requirement. 

To gain PMA, manufacturers of Class III devices must provide sufficient scientific evidence that their products are safe and effective. Applicants must receive FDA approval for their PMA application before marketing and distributing their device. Without approval, the Class III device would be considered unsafe for human use and cannot be marketed.  

FDA Clearance for Medical Devices 

FDA clears some types of lower-risk (Class I and Class II) medical devices, a form of marketing approval also known as a 510(k). However, most Class I devices don’t require clearance by FDA. 

510(k) is a premarket notification that medical device companies submit to FDA which demonstrates that their device is substantially equivalent to another device on the market that has already been determined safe and effective for consumer use. In other words, it must be substantially equivalent to a device that doesn’t require premarket approval. 

While most Class I devices are exempt from 510(k) clearance, most devices that need premarket notification are in Class II and must follow performance standards or Special Controls. 

FDA considers a majority of Class I and some Class II devices exempt from 510(k) clearance. These include: 

• General Biological Products 
• Diagnostic substances for laboratory tests 
• Clinical chemistry and toxicology devices 
• Hematology and pathology devices 
• Immunology and microbiology devices 
• Anesthesiology devices 
• Cardiovascular devices 
• Dental devices 
• Ear, nose, and throat devices 
• Gastroenterology-urology devices 
• General and plastic surgery devices 
• General hospital and personal use devices 
• Neurological devices 
• Obstetrical and gynecological devices 
• Ophthalmic devices 
• Orthopedic devices 
• Physical medicine devices 
• Radiology devices 

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

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More About How FDA Approves 

Not ready to register yet? Keep reading about FDA cleared vs approved and how it works for regulated industries. 

• How To Get FDA Approval 
• Medical Devices 101: Controls and Classifications 
• FDA Regulations for OTC Human Drugs