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FDA Regulatory Requirement Changes

Philadelphia medical device lawyers represent victims of FDA-approved devices.Implanted medical devices can save lives or restore mobility, but many of them have proven to have unforeseen consequences long after implantation. While medications must go through a human testing process prior to approval by the U.S. Food and Drug Administration (FDA), that is not the case with many medical devices. Currently, manufacturers going through the FDA’s 510(k) regulatory review process can use data showing a new medical device is the substantial equivalent of a device already on the market. That could mean the former device was not tested, and the new device is not tested, either. The FDA is currently working toward making regulatory requirement changes.

Human Guinea Pigs

Many patients receiving medical implants do not realize they are human guinea pigs as many devices were not previously tested on people or animals before FDA approval. If failure of a device is life-threatening, some human testing is required, but the failure of many medical devices on the market is not considered life-threatening per se. The result has been hundreds of thousands of lawsuits and settlements as devices malfunction once implanted, or there are unforeseen side effects. For example, many hip implants have been recalled, as patients report serious pain and swelling from the devices.

It also turns out that hip implants with plastic components may cause bone weakening in patients. Pelvic mesh implants for urinary/gynecological and other issues may harden or break off, causing severe pain and infection. The injuries caused by these implants are often extremely debilitating, so that victims can no longer work and their qualify of life is deeply affected. Such patients may need multiple surgeries to remove devices and any broken-off pieces, as well as antibiotics and other medications to combat infection and pain.

Proposed Regulatory Changes

The FDA’s proposed changes include no longer accepting manufacturer data on marketing applications for a new device if it is based on another device that is more than 10 years old. The FDA will also pay closer attention to how these devices perform once they are approved, rather than depending on patient reports of issues as is the current protocol. The 510(k) name is being retired, replaced by the more illustrative Safety and Performance Based Pathway.

Manufacturers’ Response

For the most part, medical device manufacturers are not opposed to the FDA regulatory requirement changes, viewing them as reasonable. However, medical device manufacturers do not want the same stringent standards applicable to pharmaceutical manufacturers applied to them. There is an important distinction between problems with medications and problems with medical implants. If there is an issue with a drug, the patient can stop taking the medication. An issue with an implant requires surgical removal.

Philadelphia Medical Device Lawyers at Brookman, Rosenberg, Brown & Sandler Represent Victims of FDA-Approved Devices

If you or a loved one has been the victim of a defective medical product approved by the FDA, you need the services of the experienced Philadelphia medical device lawyers at Brookman, Rosenberg, Brown & Sandler. We will fight to protect your rights and obtain the compensation you deserve. Call us today for a free initial consultation at 215-569-4000 or complete our online form. Located in Philadelphia, we serve clients throughout New Jersey and Pennsylvania, including Delaware County, Chester County, Philadelphia County.