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