The past few years have seen numerous recalls of faulty or dangerous medical devices—from hip implants to synthetic surgical mesh products and many more in between. Now, law makers are trying to make products safer for the public by introducing legislation, such as the SOUND Devices Act, which will make it harder for manufacturers to get new devices approved.
Currently, the FDA allows products to receive a quick approval for public sale if they are "substantially similar to a device already on the market." While this rule used to apply only to devices that had been on the market for years, without incident, continued legal revisions and 'streamlining' have allowed products to enter the market without clinical testing or any proof that they actually work.
The legislation proposed by Representatives Rosa DeLauro, Edward Markey, Jan Schakowsky and Henry Waxman seeks to close the "substantially similar" loophole, hopefully keeping unsafe products away from unsuspecting consumers. Among the requirements laid out in the Act, companies filing for device approval using the "substantially similar" clause would have to inform the FDA if any of the new device's predicates have caused harm and, if so, how their device corrects the problems of past mechanisms. The Act would also give the FDA the authority to reject a new device based on a predicate that had been recalled or removed from the market because of safety issues.
While it is encouraging that law makers are taking steps to keep unsafe medical devices off the market, more work clearly needs to be done. Too many people are hurt by dangerous medical devices and drugs each year for one piece of legislation to correct the problem. If you have suffered a medical injury as a result of a dangerous device or drug, a
medical injury attorney from Arnold & Itkin is happy to schedule a free and confidential consultation with you. Securing an experienced medical injury attorney provides you with the best chance of receiving appropriate compensation for your injuries, so make the call today –
contact Arnold & Itkin, LLP.