Why Do We Need FDA Approval?

Patient and friends often ask me why medical care is so expensive. Healthcare costs in the United States are more expensive than in any other country in the world. Why? The answer is complicated. On the one hand, healthcare innovation is alive and well in our country, with new devices and medicines becoming available every year. On the other hand, an often overlooked reason is that the US has an enviable safety record for these innovations because of the Food and Drug Administration.

The FDA is responsible for reviewing and approving new medical devices and prescription medications. This is a long and expensive process which involves proving that the device or medicine is safe for users and effective at the purpose for which it is intended. When a manufacturer creates a new device or medicine, the company works with the FDA to achieve approval for the sale of the device or medicine in the US. This may involve safety testing in animals or cell cultures before testing on humans. Patients must then volunteer to be in a medical study to test the intended use of the device or medicine. The manufacturer must warn volunteers about potential adverse events associated with the device or medicine. Many study volunteers decline to participate or withdraw from studies due to safety concerns. If the device or medicine is not found to be effective, then the company’s investment in research is lost.

By the time a company is successful in getting FDA approval for a new medical device or prescription medication, the company has already invested millions of dollars in research and development. When the company begins to manufacture and sell the product, the pricing must include the cost of manufacturing, marketing and research. The company must also make a profit on the device or medication, so that investors in the research are repaid. Lastly, patent protection for medical devices and medications in the US has a time limit, so the manufacturer must make back all their costs before generic drugs or similar devices can be manufactured by other companies.

By now, you can appreciate how hard it is to go from a great idea to the sale of a new medical device. It is a long and expensive process. It is important to remember that the FDA approval process was designed to protect consumers from fraud. When your provider orders a test or gives you a prescription, you can be confident that the device or medicine has been proven to be safe and effective. Our company has begun the process of seeking FDA approval for EMF disturbance technology. We will keep you informed as our journey progresses.