Industry Goes on Offense on Medical Device Approvals

A new report from the Advanced Medical Technology Association (AdvaMed) aims to stress the safety and efficacy of the current FDA process for approving medical devices to counter criticism of the process that could appear in an upcoming Government Accountability Office (GAO) report.

GAO reports released in January and May have been highly critical of the FDA’s medical device approval processes. The reports found that the agency has not met requirements to inspect domestic plants manufacturing medical devices every two years, and that FDA also faces major challenges inspecting foreign establishments. The new GAO report is expected to be released this month.

The approval process—also known as a 510(k)—is used for products that the FDA determines to be a low or moderate risk to consumers and are similar to devices already approved. A 510(k) is significantly faster—usually around 90 days—than the pre-market approval process used for higher risk devices, which can take more than 180 days. Additionally, 510(k) approval is less expensive, as companies are not required to conduct clinical trials on the products.

The industry has argued that the 510(k) process draws unfair criticism because it is frequently misunderstood despite its ubiquitous use by the FDA. AdvaMed estimates the 510(k) process is used to approve 90% of medical devices on the market.

“This process is misunderstood because people look at legislation and look at regulations, and they don’t always remember that some of these things need to be quite broad in order to apply to a whole range of medical devices. People who are not intimately involved with the process, who don’t have to put together the submissions can easily come to that conclusion,” said Susan Alpert, senior vice president at Medtronic and a former director of the FDA’s Office of Device Evaluation.

But many believe that the 510(k) process is neither safe nor effective. Last year, the process came under congressional scrutiny by the House Energy and Commerce Health Subcommittee, which reviewed the safety and efficacy of the expedited approval process in the lead-up to legislation that extends the user-fee programs for medical devices and mandates the GAO report on 510(k) approval.

In the report, AdvaMed said patient injuries that occur as a result of devices that have been approved through 510(k) are not evidence of a faulty approval system; instead, report authors highlight faulty manufacturing processes as the cause of device failure, and also emphasize the impossibility of knowing all risks associated with a device in the pre-market phase.

“Further, the long-term effects of devices will never be fully identified and problems eliminated by clinical evaluation in the pre-market period, whether the FDA review is through the PMA or 510(k) processes. In essence, the experience cited by the program’s critics is independent of the pathway to market.”

The report references the deterioration of a jaw implant made by Vitek Inc. as a case that critics use to highlight the pitfalls of 510(k) approval. The report said that injuries occurred due to manufacturing problems, not the 510(k) process.

“Based on this unfortunate experience, it has been inferred that had the device been regulated through the more rigorous PMA program, the failures would not have occurred. This line of thinking is simply flawed.”

In congressional testimony last year, National Research Center for Women and Families President Diana Zuckerman called attention to Boston Scientific’s ProteGen bladder sling, which was approved through the 510(k) process despite being made with a synthetic material different from its predecessor. After implementation, some ProteGen devices began to break down in patients’ bodies, causing major infections and significant harm.

A Boston Scientific spokesman said the company could not comment on the ProteGen device. “Due to pending litigation, it is not appropriate for us to comment at this time,” he said.

AdvaMed members emphasized the historical precedence set by Congress in permitting the FDA to interpret what makes devices similar. In 1990, Congress codified the FDA’s definition of “substantial equivalency” as a device that maintained a similar intended use to its predecessor, and it could include technological developments if the safety of the product was not brought into question.

“Intended use is a pretty broad term, and it really gave the FDA a fair amount of discretion in determining what was and was not a new intended use. The agency typically made that determination based on risk,” said Pat Shrader, senior vice president of corporate, regulatory and external affairs at BD. “Congress did not see a need to go back and make a fundamental change, they merely adopted what FDA was already doing.”

In an interview Zuckerman said, “The problem is that the definition of what is an ‘substantially equivalent’ device has become such a loose definition that it no longer has a scientific or logical meaning. The original definition was pretty good  . . .  it did not mean you could change what the thing is made out of, and it doesn’t mean you can use a different mechanism of action.”

Alpert said the development of the 510(k) process along with technological advances in the medical device industry has allowed the FDA to keep up with industry and consumer needs.

“When the program first started most products were tool-type products. This industry has evolved significantly in 30-plus years and the program has evolved right along side that  . . .  it gives the FDA the authority and capacity to state and design specific controls for different technologies to uniquely regulate the different types of products while building off knowledge that has been gained in these many years,” Alpert said.

Zuckerman said improvements to the 510(k) process start with a redefinition of what low- to moderate-risk products are. “A lot of these devices are not of lower risk to patients. An implanted device is never lower risk — it may not be life-saving, but it could become life threatening — once you put something into someone’s body it can do some harm. Anything implanted should go through the pre-market approval process.

“The requirement that GAO do a report was just the first step in dealing with this problem, which I believe has gotten worse over time and is worse today than when I testified a year ago,” Zuckerman said.

SOURCE: cqpolitics.com