January 19, 2012 ~ In a letter to the Editor of the New England Journal of Medicine (NEJM), (here) January 19, 2012, Neil Feder, M.D. of the Project on Government Oversight writes about the 510(k) process that allows untested medical devices onto the market without premarket approval. In reference to a published piece in the Journal on the approval process, Dr. Feder says replacing the 510(k) process would require Congress to grant a huge budget increase to the FDA, which he believes is unlikely. With friends in Congress and a cry that more regulation would hurt innovation by device makers, reform of 510(k) “remains a distant hope," he believes.
The 510(k) process allows medical devices to be fast-tracked onto the market bypassing clinical trials and assurances of patient safety.
In response, Dr. Rita Redberg of the University of California San Francisco, School of Medicine writes that the Institute of Medicine, in calling for an overhaul of 510(k), notes the FDA already has the ability to require post approval studies of medical devices and to initiate recalls, something the Government Accountability Office (here) believes is underused.
Dr. Redberg reminds us that the FDA can require post market surveillance for Class II and Class III devices, as it did last week in contacting 35 synthetic mesh manufacturers with letters asking for three years of post market follow-up on patients with mesh. (background story here) The task will be for the FDA to act on the results of the followup data including expanding labeling on devices and restricting or recalling defective medical devices.
This exchange of letters refers to a September 15, 2011 here published in the NEJM Medical Devices- Balancing Regulation and Innovation by Gregory Curfman, M.D., Executive Editor of the Journal, and Rita Redberg, M.D.
It concludes that the approval process for medical devices is 35 years old and now outdated.
The article highlights how the DePuy metal on metal ASR hip implant made by Johnson & Johnson made it to the market, cleared by the FDA under the 510(k) process with a claim of substantial equivalence to another device already on the market. No clinical data was required.
Unfortunately, the device failed “at an astonishing rate” requiring at least one in eight patients to have the defective hip replaced as the metal eroded and particles migrated into the bloodstream and surrounding tissues. At least 100,000 patients have received the ASR and the resulting patient nightmare has led to litigation and disabled patients.
The ASR was eventually recalled from the market. Patient's around the world have been harmed (here).
The NEJM article commends the Institute of Medicine report July 29, 2011 (here) that concluded the 510(k) process is “fatally flawed” because it does not evaluate a device for safety and effectiveness. The author supports the IOM committee’s recommendation that 510(k) be replaced with a true evaluation of safety and effectiveness as well as:
*Supports recommendations that Class III devices not be approved through the 510(k) process.
*That multiple predicates not be used to approve a device in a sort of round robin, substantially equivalent to a device that was cleared after it was cleared based on "substantial equivalence" to another device, and on and on.
*Careful tracking postmarket is needed so data can be gathered on a high-risk device on patient safety.