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Federal regulators have issued new guidelines for a controversial fast-track approval process, which many say has been abused by the medical device manufacturing industry and allowed dangerous products to enter the market without thorough testing.
On July 28 the FDA issued a new guidance (PDF) for both its own personnel and the medical device industry on a crucial portion of its 510(k) premarket approval program.
The new guidance lays out how the agency should determine whether a medical device is “substantially equivalent” to an existing, approved device, which allows the manufacturer to introduce the product without rigorous premarket clinical trials.
The agency also released a guide on the benefit-risk factors to be considered when determining substantial equivalence for devices that have some technological differences.
Many critics say that since the program’s inception in the 1980s, the term “substantially equivalent” has become nearly meaningless.
At the same time many medical device manufacturers have been obtaining approval for devices like hip replacements and transvaginal surgical mesh by claiming they are nearly identical to previously approved devices, they have engaged in marketing that extolled the virtues of the devices, claiming that they are vast improvements that utilize “revolutionary” designs or new materials never before used in previous devices.
Originally designed for non-critical medical devices, like band-aids and tongue suppressors, the program has expanded over the years to include numerous medical implants, such as surgical mesh, artificial joint implants, defibrillators, stents and other critical devices that are implanted into the human body.
The program has come under increasing fire over the last several years due to the number of recalls involving 510(k) approved devices, which were only found to carry unacceptable risks after they had already been implanted in thousands of patients.
In the new guidance, the FDA defines substantial equivalence as having the same intended use as the predicate device and that it has the same technological characteristics as the predicate device. If it has different technological characteristics, the application for approval must include information showing that the device is safe and effective and that the changes do not raise different questions of safety and effectiveness than the original device it is based upon. The required information could include clinical or scientific data depending on what the agency requires in that particular case.
“Demonstrating basic similarities between a new device and a predicate device typically requires manufacturers to provide descriptive information such as a comparison of specifications, materials, and technology,” the guidance states. “In contrast, FDA generally evaluates differences between the new device and the predicate device to determine their effect on safety and effectiveness. It follows that the evidence necessary to show substantial equivalence will increase as differences between the new device and the predicate device increase if those differences significantly affect, or may significantly affect, safety or effectiveness.”
Program Leads to Untested Devices, Harsh Criticisms
The guidance is unlikely to quell criticism of the program, which many say is fundamentally flawed.
While the public generally assumes that the older devices, which are the basis of approval for the new devices, were at some point tested, that is often not the case.
Many medical devices were “grandfathered” into the 510(k) program, without required testing. That means that there are multiple generations of some invasive medical implants, each one slightly different from the last, that have never, throughout their entire history, undergone clinical trial to ensure they are safe or effective.
Both the Government Accounting Office (GAO) and the Institute of Medicine have called for overhauls of the program, and lawmakers have introduced legislation to change how the FDA approves devices, but those bills have gone nowhere.
A report by Consumer Reports in early 2012 found that most medical devices now being used on Americans were never tested before being placed on the market because of the 510(k) program, which only costs medical device manufacturers $4,000 in fees.
The report noted that even when medical devices are required to undergo a full approval process, which is rare, they face less thorough testing than those required by the makers of new drugs.
Another report issued that year by Congressman Edward Markay found that many of the devices approved were known to have significant safety problems before being submitted to the FDA. According to the report “Defective Devices, Destroyed Lives,” the 510(k) process leaves open dangerous loopholes that allow manufacturers to continue to get devices approved even when they know there is a safety risk and the FDA can do nothing to prevent it.
The issue came up again most recently at an FDA advisory committee hearing over power morcellator cancer risks.
Power morcellators are medical devices that are used during a laparscopic hysterectomy or myomectomy for uterine fibroid surgery. The devices cut up the uterus or fibroids into small pieces, which doctors are able to remove through a small incision in the abdomen, reducing the risk of surgical complications and minimizing recovery time.
More than a decade after the devices gained wide-spread use in hundreds of thousands of procedures, the FDA issued new warnings in April 2014, urging doctors to stop using power morcellators due the risk of spreading cancer.
The FDA determined that many women who undergo the procedure have undiagnosed forms of uterine cancer, like sarcoma and leiomyosarcoma. The morcellators inadvertantly can spread the cancerous cells around inside the woman’s body cavity, immediately advancing the cancer from its earliest, most treatable stages, to its most dangerous and deadly with no warning that the woman even had cancer.
At the hearing, Dr. David R. Challoner, chairman of the Institute of Medicine (IoM) Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process noted that the power morcellator was another child of the 510(k) program that had avoided premarket testing. The FDA is now weighing recommendations to either place a black box cancer risk warning on all power morcellators, or to issue a power morcellator recall and ban the devices from use during uterine fibroid removal.
“After nearly 4 decades, at a time of rapidly changing science and technology questions persist about whether the 510(k) process is protecting the public’s health,” Challoner wrote. “Unfortunately, the sad saga of the evolution and modification of morcellation devices for gynecologic use under 510(k) clearance adds yet another example to the need to reconsider the safety and public health protection of this process.”
In 2011, Challoner and the IoM wrote a report calling for an end to the 510(k) program to better protect public health. However, Challoner says the medical device industry pushed the FDA to choose expediency over public safety, resulting in medical devices, like power morcellators, which are only found to be health risks after being used on countless patients.
On July 30, Johnson & Johnson’s Ethicon subsidiary announced a power morcellator recall, saying that the cancer risks were too great and that it was exiting the morcellator market entirely. The company commanded 72% of the power morcellator market.