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Legal & Regulatory Feature

Courtesy of United States Congress and Wikimedia Commons

New Bill Streamlines Medical Device Process

Jessica Mehta • Fri, June 9th, 2017

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Could the Food and Drug Administration (FDA) review process be faster and easier?

Two members of Congress—a Republican and a Democrat—think so.

Representatives Mimi Walters (R-Calif.) and Ami Bera (D-Calif.) introduced bipartisan bill H.R. 2474, the Medical Product Review Harmonization Act of 2017, on May 16, 2017 “to provide an alternative standard for substantial equivalence determinations for devices.” Their goal is to streamline the 510(k) review process for certain medical devices via an alternative, simpler standard. The bill was referred to the House Committee on Energy and Commerce on May 16, 2017.

According to a statement by Walters, a big part of recent advancements in medical care is due to “the innovation of the instruments and devices that carry out the procedures and keep us healthy.” However, she says the red tape medical device manufacturers have to wade through hinders advancement and progress—even taking lives in the process that might otherwise be saved.

If passed, the legislation would tackle “repetitive and burdensome regulations in the review process for certain low- to moderate-risk medical devices.” Class II medical devices are the target. The FDA classifies medical devices in three categories, with one being the lowest risk and, subsequently, subjected to the fewest controls. An example is dental floss.

Class II devices are a higher risk than their Class I counterparts and currently demand more controls. According to the FDA, “most medical devices are considered Class II devices.” Class II makes up 43% of all medical devices and covers everything from powered wheelchairs to condoms. Although researchers at the University of Pittsburgh Medical Center in Pennsylvania said in their study “The Classification of Implants” that “Class III is the most scientifically rigorous classification of medical devices and encompasses most of the orthopedic implants on the market today,” there are still plenty of medical devices utilized by orthopedic surgeons which fall into the Class II category. However, the list of class devices is so enormous that the FDA offers a search tool in lieu of a complete list.

Class III devices pose the highest risk and come with the higher control regulations. They almost always require FDA approval before being marketed. Along with orthopedic implants, complex devices like replacement heart valves are considered Class III.

With 43% of all medical devices falling into Class II categories, Walters and Bera have their work cut out for them.

Supporters of the Bill

A number of supporters have made statements supporting the bill, including the Advanced Medical Technology Association (AdvaMed). The group is an ally for device makers. AdvaMed’s CEO and President Scott Whitaker said the proposed streamlined approach “does nothing to change FDA’s robust requirements, but would allow a more efficient process for both the agency and product sponsors.” He also pointed out that the FDA already has certain testing, requirements and controls in place for the low- and moderate-risk devices the bill is targeting that have already earmarked them as “safe and effective” before receiving marketing clearance. Offering these pre-approved devices a quicker and easier route to market may benefit all parties.

The FDA’s current review process means that devices aren’t allowed to be cleared simply because they’ve achieved these requirements. Sponsors also have to give their okay on devices after they’ve proven themselves to be similar to like devices on the market. “This means that FDA must review duplicative and redundant information, which is inefficient and delays patient access to needed advancement,” Whitaker said.

According to Bera, “We owe it to Americans to take an honest look at what regulations are helping patient safety and which ones are getting in the way of better, more affordable health care. This bill helps us streamline some of these cumbersome processes.”

Amy Baxter, M.D., founder and CEO of MMJ Labs, LLC, points out that the U.S. spends $60 billion per year on pain relief, but just 2% on devices. “There aren’t many options,” she says. “Class I devices may not work.” For example, there are numerous pain relief devices based on TENS (transcutaneous electrical nerve stimulation) electrical stimulation, but the low intensity of Class I devices is “too wimpy” to activate the aB pain nerves, so the less regulated devices often don't work. According to Baxter, “New FDA regulated devices for pain (such as VibraCool or Willow Curve [by Physician’s Technology, LLC]) take too long to get to market. The time and expense are barriers to small innovative companies. By speeding clearance of low risk devices, patients may have more options.”

Joseph Braithwaite, a business consultant who has worked with a variety of corporate clients, agrees with Baxter. He says, “The overly burdened FDA has been the gatekeeper for the Pharma world for many years now and has developed both a robust set of protocols and an increasingly large army of pundits that want more, faster.” Braithwaite can see some of the reasoning behind the FDA umbrella, but points out there are alternatives available—and the FDA keeps “dragging their feet on [possibilities] that have real impact on people’s lives.”

Braithwaite has his own ideas on how the FDA might work with the proposed bill.

“In my view, one option for the medical device approvals could be to apply a ‘monitoring’ period overtop of any market approvals. [Somewhat] similar to the FDA REMS [Risk Evaluation and Mitigation Strategy] protocol that forces adverse reactions to drugs to be reported to the FDA for follow-up and evidence during future review cycles. Tracking programs like this might add a level or two of reviews, but it would get the needed devices into the hands of the needy sooner with minimal additional risk (there is an inherent risk in new technology releases anyway). Finding ways to increase the speed of reviews would allow for technology to be approved for the market sooner, and it would start the fine tuning cycle earlier, ultimately a benefit for everyone.”

Both Walters and Bera did not respond to requests for additional comments. Spokespersons for the FDA declined to comment.

On Another “Note”

Not everyone is a fan of the proposed bill. John D. Risvold, associate attorney as The Collins Law Firm in Naperville, Illinois, says that it may lead to the risk and likelihood that ‘low or medium risk’ devices actually turn out to be high-risk devices. He says, “The risk is that these devices have not been thoroughly tested and there is not sufficient oversight to ensure that they present the lowest risk possible. A moderate risk device still is a foreign body being implanted into our bodies.”

For orthopedics, Risvold says that although some are classified as Class II, others—such as hip implant devices—have been the subject of thousands of lawsuits due to their dangerous propensities. By reducing the oversight and review process of medical devices in order to get them more quickly to market, it’s not enhancing patient safety. Risvold urges that, “Thorough testing, oversight, and review of these devices are necessary to protect consumers, patients and doctors/medical professionals alike.”

Tara Britt, strategic account manager for the healthcare practice PrincetonOne, says that Class II devices can take anywhere from 20 – 90 days for review. “There is very little information available regarding this new bill to help streamline Class I and Class II devices. We have not really heard companies discussing this in the marketplace very much.” She says that even though Class II devices are low-risk, if this bill were passed, “companies would have to rethink their workforce strategies.” For example, they would take an aggressive strategy around “Regulatory and Testing” as these two areas would make the difference for the commercialization of the product and in keeping both the company and the public safe. “Companies would move potential products more quickly through their pipeline, indicating hiring more in the areas of R&D, engineering, marketing, sales and operations.” Another area that would be affected would be independent safety, regulatory and 510(k) consultants. “If there are more products, the demand in this area would also increase.”

It’s All in the Details

Specifically, the bill would amend Subsection 513(i)(1) of the Federal Food, Drug, and Cosmetic Act (FDA). Inserting an alternative process would entail a person having the ability to submit information to the Secretary of Health and Human Services “that demonstrates that a device conforms with national or international standards, standards established or recognized…or guidance documents developed by the Secretary to demonstrate that a device is as safe and effective as a legally marketed device, notwithstanding technological differences.”

The bill details that “any person” can submit information to the Secretary and that a response is required within 60 days. The Secretary may approve all, some or none of any submitted proposals but must state the “full rational” behind the decision. The bill is also asking to add the following statement to the current verbiage:

The reliance on standards or guidance documents to demonstrate substantial equivalence…shall be optional and have no effect on the establishment of substantial equivalence…where such option is not exercised.

Currently, the bill is not being “fast tracked,” in which case any outcomes are likely to be several months down the road.

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