FDA Safety Guidelines for Medical Devices
Written by Faith Anderson on August 16, 2011
Medical Device Risk-Benefit Determinations
Before approving premarket applications for medical devices, the FDA uses both safety and effectiveness data to weigh the product’s risks against the benefits. Safety data takes into consideration potential risks and the manufacturer’s ability to mitigate that risk. Effectiveness data addresses the possible benefits of the medical device, as well as other information, to determine whether the possible benefits of the product outweigh the potential risks. Other factors the FDA considers when reviewing premarket approval applications include the severity of the condition the device treats or diagnoses, and whether or not alternative treatments or tests are available. These new FDA safety guidelines were established to provide manufacturers with definitive information about the safety and effectiveness factors the FDA considers when making benefit-risk determinations.
New FDA Safety Guidelines Intended to Prevent Consumer Injury
In addition to implementing new safety standards, the FDA guidance proposes that reviewers of medical devices use a worksheet to document how they make benefit-risk determinations. By doing so, the FDA’s decision is even more transparent, and physical evidence in the form of the worksheet could then be made public later on, if necessary. The FDA is an agency within the U.S. Department of Health and Human Services which is responsible for protecting the public health. In order to do so effectively, the FDA assures the safety, effectiveness and security of medical devices, and human and veterinary drugs, vaccines, and other biological products for consumer use. In addition, the FDA is responsible for the safety and security of the U.S. food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. The FDA is an important agency because it provides consumers with critical information about pharmaceutical drugs and medical devices so that consumers can make educated decisions about which products are safe for them to use. With the introduction of new safety guidelines for medical devices, the FDA is taking steps toward improving the medical device approval process, thereby potentially decreasing the frequency of consumer injury in the future.