What is FDA?
The U.S food and drug administration is the agency with health and human services (HSS) that keep checks upon the manufacturing and supply of food, pharmaceuticals, medical devices, tobacco and other consumer products and veterinary medicine.
Its main responsibility is to protect and promote the health of public by keeping regulatory over food and drugs safety.
The need of controlling the supply of food, pharmaceuticals supply, medical devices and other such products is at high stake.
The mission of FDA is clear and loud. It works for the public to protect their health by ensuring the safety and security of human health and veterinary drug. There are multifarious agenda that needs to be taken care of, for the efficacy of public health and veterinary medicine.
FDA has accountability for manufacturing, marketing and supply of tobacco products so it doesn’t land into the hand of minors and also for reducing the risk of public health.
FDA also regulates the swiftness of innovation that makes medical device more effective as well as innocuous and affordable for public so that they can get the assistance of technology which is reliable, science-based and accurate to improve their health.
Protecting the public from electronic product radiation is also the one of the main responsibilities of FDA.
FDA also works with private sector and other government agencies on activity related to food defense. FDA has established plethora of tools and resources to help food facilities avert and recover from acts of intentional adulteration of the food supply.
WHY the approval is needed?
It is necessary for public health that some drugs and complex medical devices should be proven secure before company can put them in market.
If this is not taken care of then it may happen that the use of tobacco or drugs may increase and it would be threat to the civics.
Food additives are also needed to get approved before using them in food.
Medical devices such as X-RAY machines or Microwave ovens must measure up to standard performance.
Plethora of things are kept in check before reaching in hands of public.
WHAT is the FDA medical devices?
A medical device is any apparatus, software or material that is used for the diagnosis, mitigation or treatment of any disease or abnormal physical condition.
It is to be make sure that the apparatus kept in market for the treatment of public are innocuous and its application is standard for use.
The medical devices are classified based on the level of control necessary to assure the safety and effectiveness of the device.
They are classified into three different groups:
Device classification is based upon the intended use of the device.
- Class I : General controls
They present the lowest potential risk and do not require a license.
- Class II : General controls and Special controls
They require the manufacturer’s assertion of device safety and effectiveness
- Class III : General Controls and Pre-market Approval
These device usually sustain or protect life and present potential risk of illness or injury.
WHICH medical devices need FDA approval?
Not all medical applications/device needs FDA approval. There is a different category of mobile applications which analyzed data or provide the treatment of specific disease or deliver drugs, requires approval.
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Below are lists of few app examples which needs FDA approval:
- The apps which analyze the data of patient reports of specific disease.
- The apps which control the operation or function of medical device.
- The app which licensed practitioner can use to diagnose a medical condition.
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