With the number of recalls and new drug warnings issued lately, the FDA’s approval process has been in the news a lot. There have been so many cases of drugs causing problems and what the approval means that there have been a number of Supreme Court cases attempting to determine whether or not the makers of various drugs and medical devices are liable for their products malfunctioning or adverse side effects since they have already been approved by a federal independent agency.
The FDA approval process for medical devices, such as Medtronic’s defibrillator leads, includes everything from bedpans to pacemakers and implantable defibrillators. When problems started popping up, people questioned why the Food and Drug Administration’s tests concerning the leads didn’t catch the problems. In this instance, the reason is that the tests weren’t very extensive. Because the SprintFidelis leads that were problematic were an improvement to a previous bit of technology, they were not subject to the entire approval process.
When a new product is up for approval, the first step for a medical device’s approval is to check that the device is actually a medical device. This might seem like a no-brainer but medical devices, as defined by the FDA, encompass everything from bed pans and tongue depressors to in vitro technologies and medical pumps. This is a wide range of items with varying degrees of seriousness if something goes wrong. If a tongue depressor does not function properly, it is generally not a question of life or death. A lead on a pacemaker or defibrillator that breaks is a slightly more serious problem. In addition to rules concerning whether a bit of medical device is a new technology or an improvement to an existing product, there are different rules concerning whether or not a device emits radiation.
Once it has been determined that a piece of technology is actually a medical device, the device must be classified. Unless the innovation is exempt, the FDA will do this for the inventor or manufacturer. This classification identifies the level of regulatory control that is necessary to ensure the safety and effectiveness of the product. The classification of a device also determines the proper procedures the manufacturer or inventor must go through in order to obtain FDA approval for sale and marketing. The two options for a device are Premarket Notification (510K) or Premarket Approval (PMA).
After the first two steps have been completed, data must be gathered and necessary information must be gathered in order to submit an application for approval. In almost every case, clinical performance data is required. This data must be collected from clinical trials that are subject to FDA regulations as laid out n the Investigational Device Exemption booklet.
Finally, after all of these steps are completed, the FDA must review the application and determine whether or not the device is suitable for marketing and use in the United States.