We all use medical devices and other goods at some point of our lives. When medical professionals recommend purchasing a certain medical product, we trust their medical knowledge and expertise to purchase and invest in that product. Although there are well known companies that produce medical products, there are also companies that are new to the industry but already offering an array of products in the market. Many heavily depend on products that are FDA approved, but it is necessary to know that not all products undergo premarket approval by FDA experts for safety and effectiveness. In many cases, FDA testing is only done after they have been placed in the market. As such, there are other ways companies can assure customers that their products are safe and effective and this is done through product testing services.
Must Companies That Manufacture Medical Goods Be Approved?
Many people assume that companies that manufacture medical goods must be FDA approved, however this is not so. The agency does inspect the companies to verify that they comply with the manufacturing process of medical goods, but they do not approve the company or the manufacturer. When new drugs or goods are introduced, they must be first proven safe and effective to the FDA prior to marketing. As such, the agency does not develop nor manufacture these new drugs and goods, except regulate them. When these goods are approved, then it means that the agency test results confirm that the benefits being offered by the goods are greater than potential risks. However such risks must be indicated on medical packaging to advise medical professionals and patients.
Are Medical Devices Without FDA Approval Safe?
Devices that are high risk require FDA approval prior to marketing. Such devices involve mechanical heart valves and implantable infusion pumps. Manufacturers of such devices need to demonstrate that these devices provide effectiveness and a reasonable assurance of safety before they can be approved. However, there are also moderate risk medical devices that can be manufactured and marketed if they are determined to be equivalent to the legally and already marketed device of the same type. These devices are medical equipment such as dialysis equipment and catheters. Low risk medical devices such as bandages are exempted from premarket review if they are made for the same purpose and of the same technology.
Before medical devices are set for FDA approval, manufacturers and companies can first have their products undergo product testing by a third party. An array of tests is made on the devices to ensure that they are indeed safe, effective, of quality and serve the medical purpose intended. If any risks may surface, the benefits must outweigh them and such risks must be of a minimum threat to the safety and health of a patient. This type of product testing can help companies and manufacturers correct any defects or improve any faults determined by the tests.
Are All Medical Goods FDA Approved?
Not all medical devices, drugs and other goods will have to be FDA approved. While some product components may need to be FDA approved, the product itself as a whole may not have to be. This is why, doing your own research on medical devices and goods before actually investing in them is to your advantage if you are worried about their safety and effectiveness.