Understanding FDA Medical Classifications

FDA stands for Food and Drug Administration which is responsible for the classification of products used in medicine and health care. It has three levels of classifications which are applicable to all the 16 groups known as panels. Every product has some procedure to be followed in order to determine product safety. First let us know in detail about FDA classes.

What are the FDA classes ? 

Every product must follow General Controls, in order to ensure product safety. All the manufactured products regardless of their use must enable proper labelling. FDA is classified into three classes such as Class I, Class II, Class III. These are classified based on two factors. First one is the degree of risk and second one is intended use of the product.

Class I

These are less harmful( little to no risk) and almost 47% of the products fall into this category. Majority of the products are exempt from FDA regulation and don’t require premarket notifications. Companies which make such products need to be listed with the FDA and provide relevant information. These products have minimal contact with the skin.

Example : Stethoscopes, adhesive bandages, tongue depressors.

Class II

They represent medium to high risk. This type of items need to be FDA approved after the manufacturer submits a formal application. Almost 43% of the products fit into this group.

Example : wheel chairs, birth control, hypodermic needles and ventilators.

Class III

These devices come under the highest risk group and must undergo stringent evaluations with clinical trials.

Example : Pacemakers, heart stents

How Can I Find Out What Classification My New Product is in ? 

First one is to compare similar products that are already listed on the FDA website. Second one is to submit your application.

What are panels ?

Panels are nothing but groups divided based on the medical specialty.

Example : Cardiology, neurology, dental, orthopedics.

What is the importance of ISO 13485 ?

We have many ISO standards which is a license to the products. But this is not the license, instead it is a set of guidelines a manufacturer follows. They demonstrate risk assessment, quality control, traceability which are essential for maintaining the supply of medical devices.

So the medical device manufacturers rely on ISO 13485 when submitting a new product to the FDA.

Finally we need to follow all the norms and regulations for ensuring product safety and proper use of the medicine.

Image Source: star rapid

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