Medtronic Lawyer, Williams Kherkher

FDA Approval

When problems with Medtronic’s internal defibrillators started popping up and the leads were blamed, many people looked to the FDA wondering why their approval process didn’t catch the problems that have been occurring. The reason is that because the Sprint Fidelis leads were an improvement of a previously existing product, they were not subject to the generally standards of approval discussed below.

The first step to FDA approval is making sure your invention or innovation is actually a medical device. This may seem like a straightforward thing but a medical device covers anything from a bedpan to a tongue depressor to in vitro technologies. Then there are the different rules if the device emits radiation. It’s not nearly as simple as it seems but it’s really the most important step.

The next step to gaining FDA clearance is classifying the device. Unless an innovation is exempt, the FDA will classify the device for the inventor. Classification then identifies the level of regulatory control that is necessary to ensure the safety and effectiveness of the product. It also determines the marketing process the manufacturer must complete in order to obtain FDA approval for marketing. The options are either Premarket Notification (510K) or Premarket Approval (PMA).

The third and final step involves development and gathering of data and or any necessary information to submit an application for approval. Clinical performance data is required in most cases and any clinical trials must be carried out in accordance with the FDA’s Investigational Device Exemption regulations.

If you or someone you know has been treated with a Medtronic implantable defibrillator, contact the Medtronic lawyers of Williams Kherkher in Houston at 800-761-3187 to schedule your consultation.