• by Signup Training

The FDA is responsible for informing the people of USA about which foods, drugs and medical devices are safe for use. The Food and Drug Administration evaluates the safety and efficiency of these products. If a product is FDA certified it means that the regulatory authorities have found the benefits of these items to overweigh the risks associated with them. It is only when medical devices are approved by the FDA that they can be sold over-the-counter, for commercial purposes.

We look at some of the reasons medical devices need FDA approval below:

1. Wide Spread Usage

To have a serious impact in the market, medical devices need to be approved by the FDA. FDA approved devices are considered to have proven affects with low chances of repercussions. Non FDA approved products will have a limited market. Distributors and sellers are more likely to agree to sell FDA products in their stores than the non-approved ones.

2. Sell in International Markets

An FDA approval certification means you have the approval to sell in international markets like Brazil, China and other countries. All FDA approved products have permission to be marketed and exported from USA. It is an easy route to start setting in new markets.

3. Builds Credibility

An FDA approval is a sign of promise that gives customers the satisfaction that the products have gone through rigorous tests and trials before being approved for public utilization. The FDA brand is well-known and associated with safety. Having the FDA approval stamp is a big step towards getting more customers.

4. Investor Funding

Having an FDA approval makes it easier for manufacturers and distributors to get funding from investors and VCs. The VCs do not have to spend additional time and resources in getting the products verified, as this step has already been done by the FDA. It also goes to show that this product has proven its worth to customers.

5. Entry into Hospital Chains

Hospitals are extremely careful about associating their names with any particular medical device. But, with an FDA approval certification it will be easy to enter this network and convince them to promote the product across their chains in the US.

These are just a small list of benefits of getting an FDA approval for your medical device.But the advantages way surpass this. As a manufacturer, you get a lot of insights and support from the FDA to further market your product and even expand to build more devices. So, you should actively consider getting an FDA approval for your product.

To understand more about Medical Devices and FDA approvals sign up for our course on www.signuptraining.com