FDA approved vs FDA cleared

Dr KK Aggarwal

(CNET Excerpts): The FDA (DCGI and FSSAI) is responsible for telling us which foods, drugs and medical devices are safe for us to use.

There is a big distinction between a drug or medical device that has been FDA approved and those that are FDA cleared. It's important to understand the difference.

What does the FDA regulate?

·         Prescription drugs for humans and animals

·         Over-the-counter drugs

·         Biologics (e.g. vaccines, blood products, biotechnology products and gene therapy)

·         Dietary supplements (not all are subject to FDA regulation)

·         Medical devices (everything from tongue depressors to pacemakers)

·         Surgical implants

·         Food additives

·         Cosmetics

·         Products that give off radiation (e.g. X-rays, microwave ovens)

·         Nicotine replacement therapy  (NRT) products

·         Infant formula

What does 'FDA approved' mean?

"FDA approved" means that the agency has determined that the "benefits of the product outweigh the known risks for the intended use."

Manufacturers must submit results of clinical testing in order to get approval.

When deciding to approve a product or drug, the FDA has to decide if the benefits outweigh the risks. The FDA is usually inclined to approve a product that has a higher risk if the potential benefit is significant -- like an artificial heart valve that can save someone's life.

What products need to be FDA approved?

FDA approval is usually mandatory to market or sell products that might have a significant risk of injury or illness, but can also benefit your health -- such as prescription medications, over-the-counter medications, vaccines and Class III medical devices.

The FDA categorizes medical devices into Class III, Class II and Class I. Complex medical devices that are implanted in your body, are life-sustaining, or have the potential to cause significant injury or illness in the body are in Class III. Those include implanted pacemakers, replacement heart valves and even breast implants.

Lower-risk devices and products used outside of the body, like condoms, motorized wheelchairs and bandages, fall into Class II and Class I. For reference, Apple's ECG app for the Apple Watch is in Class II.

What does 'FDA cleared' mean?

Class II and Class I medical devices are usually "cleared" by the FDA, which means the manufacturer can demonstrate that their product is "substantially equivalent to another (similar) legally marketed device" that already has FDA clearance or approval. Those already-cleared products are called a predicate.

Once the FDA declares that a new medical device is substantially equivalent to a predicate, it is "cleared," and can be marketed and sold in the US.

The system isn't perfect

The problem with the FDA's approval system is that often companies get their product cleared by using older predicates that were recalled for safety reasons.

FDA does not develop any of the products it evaluates for approval. Nor does it conduct its own testing -- instead, it reviews the results of independent lab and clinical testing to determine if the product, drug or food additive is safe and as effective as it claims to be.

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA