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Tag: FDA approved

How to get new medical device approved?

medical device compliance
medical device compliance

If you are trying to market a medical device, the Food and Drug Administration, or FDA, must clear your product for medical compliance. There is a rigorous process and there are fees involved as well. Medical devices can fall under three separate classes that are relevant to the FDA compliance approval process, and, in the following, they are explained in much greater detail. Getting a medical device approved can be done a couple of different ways.

Classification

After you put together your creation, you must determine what classification it is. The three classes are simply known as class I, II, and III. What property earns the devices this classification is usually the risk it offers users. The lowest level, class I, is associated with devices that are not harmful to consumers in any way. Tongue depressors and thermometers are both types of class I devices. These have a relatively easy procedure to follow to get approved by the FDA.

How to Get a New Drug Approved

PDA Approved
PDA Approved

Companies that make drugs are always analyzing various compounds trying to find the ones that have the most therapeutic value. There are many steps, millions of dollars, and thousands of man hours spent on trying to get a medicine approved by the FDA. There are many steps to get your product approved before you can sell it on the open market.

Perfection and Preclinical Testing

During the first six or seven years of preclinical testing the synthesis and purification of a drug gets perfected by the manufacturer. Limited animal testing applies as well. Out of thousands of compounds that are tested, only a few will appear to have enough promise to induce a company to file an IND, or Investigational New Drug Application. If the FDA approves the IND and an Institutional Review Board approves them as well, the manufacturer can start the first part of development.