Medical Device Approval Process Is Defective

The Institute of Medicine released a study on Friday July 29 2011 concluding that the regulatory framework in the U.S. for the fast track approval and release of moderate risk medical devices into the market is itself flawed and fails to offer assurances of safety for patients.The IOM study committee made 3 important findings:

1. the Food and Drug Administration has a broad array of tools available to address safety concerns in the postmarket period but that the agency does not use these tools extensively.
2. the existing regulatory process generally is not intended to evaluate the safety and effectiveness of medical devices and, furthermore, cannot be transformed into a premarket evaluation of safety and effectiveness.
3. that a number of safety issues arose on account of the lack of clarity in the use of the phrases intended use and indications for use.

The committee concluded that the framework not only lacks the legal basis to be a reliable premarket screen of the safety and effectiveness of moderate-risk Class II devices but that it cannot be transformed into one. A new framework that uses both premarket clearance and improved postmarket surveillance of device performance to provide reasonable assurance of the safety and effectiveness of Class II devices throughout the duration of their use should be developed. A comprehensive strategy should be developed and implemented to collect, analyze, and act on information about devices’ performance after clearance.

In Canada our federal regulations governing the introduction and approval of medical devices were last revised in 1998. We are seeing a lot of problems with certain medical devices such as metal hip implants and pelvic surgical meshes that have been released in both countries. We are currently pursuing a number of cases involving these devices and continue to accept cases for review. If you have a problem with an implanted medical device don’t hesitate to contact us. Additional information can be found on our medical device litigation page.

This entry was posted in medical device. Bookmark the permalink. Comments are closed, but you can leave a trackback: Trackback URL.