The vast majority of medical devices are marketed in the United States based on one of two routes: 510(k) clearance or Premarket Approval (PMA). So it’s very easy to consider U.S. regulatory strategy in terms of “510(k) vs. PMA”. In reality, there are seven routes to get on the market legally. Let’s review the seven, but not just to increase your knowledge with trivia. Instead, knowing all seven paths may help you think “outside the box” when considering the regulatory path for a new device. A review of the seven routes will also give you a historical perspective on the U.S. regulatory process.
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We kicked off our 2016 trade show season in Anaheim, CA for MD&M West – February 9th through 11th. Not only was it a nice break from the cold, snowy weather here in West Lafayette, IN, but we also had a great show! This year we featured a TA ElectroForce 3100 fatigue tester as part of our booth to show off one of our numerous testing capabilities. Last year we completed over 3 billion cycles with our fatigue testers for a single client! We also had opportunities to discuss other capabilities including R&D, simulation, regulatory, and many other services we offer.
Additionally, Brandon Davis, one of our engineers, gave a Tech Talk on Design Verification Testing: What Should You Do When a Testing Standard Doesn’t Exist? Brandon discussed the importance of being involved with standard committees to establish a new standard test method or modify an existing method. He also discussed developing a new non-standard test method and how to mitigate risk with test method validation. The talk was such a success an article highlighting its key points was published the next day by QMed! Overall, we were very happy with our booth, new leads, and Tech Talk success at the show. We are looking forward to heading back to Anaheim next year!
For a device to be used in an MR environment, it needs to be evaluated for magnetic deflection and torque. A commonly used acceptance criterion is the magnetic induced deflection and torque as compared to forces and torque due to gravity. For magnetic deflection, if the magnetic force is less than the force due to gravity, then the deflection angle will be less than or equal to 45 degrees. This is very conservative and some devices may exhibit more deflection than this and still may be safe and pose acceptable risk to patients in the MRI environment.
What do you do?
To assess magnetic induced deflection at MED Institute, we test the device at a location of a known static magnetic field (i.e., static field and spatial gradient). If the device is expected to deflect more than 45 degrees in the desired static magnetic field we perform additional evaluation to determine if the magnetic induced force causes damage to adjacent tissue, leads to device migration, or otherwise adversely affects the performance of the device.
MR safety labeling is important, because a device that deflects too much under MR scanning can migrate within the body or cause trauma to tissue. Accurately determining a device’s MR safety requires more than merely placing the device in an MR scanner and measuring its deflection.
For more information, please visit our website www.medinstitute.com.