A new piece of federal legislation has been introduced that will impact how the FDA oversees the approval of medical products.
Fort Worth, Texas (PRWEB) January 05, 2012
Opponents of the current 510(k) clearance process, which does not require clinical testing, have long pushed for its amendment in order to protect the safety of patients receiving medical devices. According to a recent article in The New York Times, “the new proposal . . . would broaden the FDA’s post approval oversight by giving it the authority to mandate that companies collect data on device performance.”
The current system allows manufacturers to market new devices without clinical testing if it is shown that new product is substantially equivalent to a device previously marketed in the United States. The flaws of this system are evident in the increasing number of recalled medical devices, particularly metal-on-metal hip implants.
Senators proposing the bill directed letters to five manufacturing companies: Johnson & Johnson, Zimmer Holdings, Boston Scientific, C.R. Bard, and Medtronic. The directive requests that each manufacturer produce information of how they track safety and recall processes regarding their medical devices.
The recall of the DePuy ASR hip replacement has caused a tremendous amount of concern that manufacturers are failing to do their part in tracking the effectiveness of their medical devices. According to The New York Times, more than 3,500 lawsuits have been filed against DePuy, a subsidiary of the healthcare giant, Johnson & Johnson. Patients have experienced adverse reactions within a few years of receiving the device, including implant loosening and metal toxicity.
DePuy recalled the ASR device in the United States after mounting complaints to the FDA and substantial information that indicated high failure rates associated with the implant. Shockingly, the recall in the U.S. came months after DePuy recalled the device from the Australian market.
The proposed bill aims to ultimately make manufacturers more conscious about their practices and the health of those patients who are implanted with their devices.
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Erin McDonald
Parker McDonald, P.C
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