The Senate’s Committee on Health, Education, Labor, and Pensions is currently reviewing a new Bill that would open up eligibility for FDA priority review for all medical devices. The Advancing Breakthrough Devices for Patients Act is trying to make quality medical devices more readily accessible for doctors and patients, but opponents of the Bill worry that it will increase the likelihood of defective medical devices hitting the market and harming patients.
Currently, the FDA only grants priority review status to the medical devices that pose the highest risks, called Class III devices. However, the legislation would open up expedited approval possibilities for all medical devices.
How Do Medical Devices Get Priority Review?
Device manufacturers submit applications to the FDA to receive priority review that will reduce the amount of time the FDA takes to make a determination on the safety of a device by allocating attention and resources to the evaluation of the application. The FDA grants priority review to devices that would significantly improve the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions compared to the standard treatment options currently available.
Defective Medical Devices
While speeding up the availability of new medical devices may sound like an improvement, if these devices are not rigorously studied before being used in or on patients’ bodies, defective devices could easily be approved.
Device manufacturers have a duty to thoroughly test their mechanisms and to produce safe products for consumers. When large companies fail to uphold these standards, they put patient’s lives at risk.