Details Of How To Get A Medical Device Approved By The Fda

All medical devices need the approval by the US Food and Drug Administration (FDA) before they can be marketed

. Any device used in the diagnosis or treatment of a medical condition may be defined as a medical device.

The aim of the approval is to check whether the products do what it claims to do in an effective manner. In case of medical devices, the approval is also necessary to know whether its use involves any sort of risk.

Every medical device needs to go through a stringent process before it is approved by the FDA. The first step in the process is to ascertain whether the product can be classified as a medical device or not.

Medical devices are categorized into three sub-sections; Class I, Class II and Class III. After determining the class of the product you need to know which path to take to get the device approved.

If the device you want to market is substantially equivalent to any product that had been approved by the FDA before May 28, 1976, you can get an approval via a pre-market notification. This is convenient and saves you a lot of hassles. All you need to do is check whether the medical device qualifies for this and you can get an approval with ease.

In case your medical device does not qualify for the pre-market notification, you need to go through the pre-market approval process. You need to conduct proper experiments and research to prove that the device functions at par with its claims.

The next step is to apply for an Investigational Device Exception (IDE) from the FDA. This application needs to be supported by the data collected from the experiments. It gives you approval to use the product but only on experimental basis, limiting its scope.

With the help of the IDE you can conduct clinical trials. These trials aim to prove that the device is effective, i.e. it does what it claims. These are also necessary to prove that the medical device would not cause any harm to the patient. It is only when you have sufficient positive results that you can apply for approval of your device.

FDA medical device approval is a complicated process. It gets even more difficult to deal with if the FDA imposes injunctions, detentions, refusals, penalties, or such others on the product. You need expert advice and help when it comes to handling such cases properly.

You need to hire an experienced lawyer proficient in handling FDA approval cases. He can help you plan strategies, offer cost effective solutions to get approval, and represent you in case of litigation.

Choosing the right attorney is of high importance as he would be capable of offering solutions for your problems. This is why you need to select someone who has a thorough knowledge of the FDA laws and has handled such cases in the past.

Expertise in the field is necessary to deal with such a case. Opt for a preliminary discussion with the attorney. This helps you to know him better and judge whether he would be suitable for your case or not.

by: Andrew White

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