Is it FDA Approved? A question that we hear and ask quite often in the medical field, from medical devices to drug to vaccines and many others, so what FDA is all about and how it became so popular around the world especially in the middle east, let’s See!
To dive into the sea of FDA as a whole, would need pages and pages cover, but in this short article, we will focus on the most primitive matters that biomedical engineers could come across when it gets to FDA.
The regulatory and inspector activities in the field of agriculture can be traced back to the late 1800’s led Prof. Harvey W. Wiley who is later named as the “Father of the Pure Food and Drugs Act”, later in 1906, the American Congress has established a regulatory entity to control and monitor food products quality in the country, with time the agency was assigned to more authorities on food and drugs but it wasn’t until 1976 that the Congress entitled the FDA to look into the field of medical equipment regulation and control.
Where does FDA get its significance from?
FDA has the final call on medical devices in two aspects; Safety and Effectiveness, and as the US medical devices market value represents a whopping 43% of the global medical devices market size in 2015 with an expected market size of 155 Billion USD by 2017 as well as being the golden standard in terms of regulations and market approvals in other “immature” markets where regulatory bodies and validation institutions are not well established yet, it is a profound, globally recognized entity.
How big is FDA?
Medical devices classifications as per the FDA
The FDA has set up a description of medical devices so vague that it includes almost everything related to healthcare from toothbrushes to pacemakers, so now there are 1,700 different generic types of devices covering 16 medical specialties, and these devices are divided into 3 classes, those 3 classes are risk-based classification, the higher the risk the higher the class (If I might say, the more invasive it is, the higher the class). Classification is important because it determines what pre-market review requirement the manufacturer has to provide the FDA with.
Pre-market requirements for FDA
There are general requirements from the FDA for any device of any classification, however, for higher classes more pre-market documentation has to be submitted according to each situation, below are the general requirements for devices:
- Devices must be manufactured under a quality assurance program
- Devices must be suitable for the intended use, be adequately packaged and properly labelled
- Devices must have establishment registration and device listing forms on file with the FDA.
FDA Approved Vs FDA Cleared
For Higher risk devices (Class 3 and some of Class 2) the manufacturer has to undergo extra procedures to get his new device in the market and there are two ways, either FDA Approved (I have something new) or FDA Cleared (Me too), to know more about that let’s look at the comparison below:
This article covers some small aspects of the FDA concept; however, I hope that it has brought some new information or refreshed some present one of this globally recognized entity.
Have a good one!
Most of the article is based on information from FDA website -https://www.fda.gov