Is FDA Really Streamlining Its PMA and 510(k) Processes?

As regulatory burdens in Europe have grown, FDA has taken steps toward streamlining. But do efforts aimed at expedited review represent progress or empty promises?

In the early aughts, if a medical device manufacturer wanted to get its product to market—any market—more quickly, it often obtained a CE Mark first. At the time, the European Commission required less clinical trial data than FDA. Even for some Class III devices, clinical data would need to justify safety claims but not efficacy. Efficacy was for the market to decide.

Over the past decade, payers have gradually demanded more data, which means the CE Mark became more burdensome, time-consuming, and expensive. Last year, with the European Parliament’s approval of a final version of the Medical Device Regulations, Notified Bodies have had their hands full, to say the least.

Between now and 2020, all device manufacturers, Notified Bodies, and suppliers have to update technical documentation to comply with new standards. If a device manufacturer is not in compliance by May 2020, it risks losing CE Mark certification. For the time being, obtaining a CE Mark for timeliness reasons is not the way to go.

On this side of the pond, however, FDA has announced initiatives to purportedly streamline the premarket approval (PMA) and 510(k) process. Much of this work goes back to the 21st Century Cures Act, enacted by Congress in December 2016, which aims to bring drugs and devices to market faster. Janet Trunzo, executive vice president of technology and regulatory affairs for AdvaMed, said certain Cures Act provisions provide an expedited path for technology that meets an unmet clinical need or addresses a public health need.

In its Medical Device User Fee Amendments performance goals and procedures for fiscal years 2018 through 2022, FDA reports the average total time to decision goal for Original PMA and Panel Track Supplement submissions will decrease from 320 days in Fiscal Years 2016 through 2018 to 290 days for submissions received in FY 2020 through 2022. For 510(k) submissions, the goal decreases from 124 to 108 days.

"The user fee program is intended to bring more predictability and consistency into the review process," says Trunzo. "Getting a predictable review in timely manner is a theme built into the user fee program."

The agency is seeking comments on the draft guidance, Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria, until July 11. The guidance's intent is to streamline the "substantial equivalence" analysis required for 510(k) submission.

FDA's Software Precertification (PreCert) Pilot Program, launched last year, aims to streamline pre- and postmarket obligations for software regulated as a medical device. "Our goal is to create a program that is aligned with how products are being developed and how quickly they come to market, as well as one that's aligned internationally with other regulators," FDA associate director for digital health Bakul Patel told MD+DI in August 2017. "This is about creating a new paradigm."

The diabetes space has also realized FDA support. On September 28, 2016, FDA approved the first hybrid closed-loop system, aka an artificial pancreas—Medtronic's MiniMed 670G. In a press release, FDA said it's working with diabetes leaders to advance artificial pancreas development.

Dexcom also benefitted from an expedited FDA process. On March 27, FDA permitted marketing of its G6 integrated continuous glucose monitoring (CGM) system. At the same time, FDA classified integrated CGMs as Class II devices, which means they can receive 510(k) clearance rather than go through the more arduous PMA path.

"This greatly enhanced our time frame," said Dexcom president and CEO Kevin Sayer. "Both sides were motivated to get the rule changes in place, which accelerated our approval."

Sayer said the company knew it may receive FDA clearance ahead of schedule and planned accordingly. However, he added that it's "all hands on deck" as the company builds inventory for a launch later this quarter.

Empty Promises?

Over the past few years, FDA has promised expedited review in a few areas. If history repeats itself, Sharon Kvistad, associate director in Navigant's healthcare and life sciences disputes, regulatory, compliance, and investigations practice, said much of this talk may be just that.

"FDA is under enormous pressure from Congress to streamline and expedite," she said. "They have initiatives, programs, and expedited pathways for novel, cutting-edge devices. They want to interact early and frequently to have a voice in the PMA process. The caveat is they will always wait until they see the data."

FDA doesn't want to risk public health by approving a device prematurely. However, in an industry where technology changes rapidly, its demands for data upon data still hamper innovation.

"For the small players, which have the ability to move faster, it's become difficult for some of that new technology to see the light of day because the FDA clearance or approval process can become so burdensome," she said.

On the other hand, FDA created a win with the presubmission program, which allows medical device manufacturers to interact with FDA to determine whether a submission is ready for substantive review. "I encourage all clients, particularly those seeking a PMA, to employ the presubmission process," Kvistad said. "Other than the time it takes to prepare documents, it's free, for now, and you get a read on where FDA's sensitivities lie. I've seen information from presubmissions used very well."

If FDA's various initiatives to streamline submission for certain medical devices come to fruition, it will benefit the medtech industry and the public. The question is whether FDA will take the risks needed to make it all happen.

"The quicker we can get products to patients the more likely insurers will approve the products," Sayer said. "The more we can accelerate technology and offer patients more choices, the better."

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"The quicker we can get products to patients the more likely insurers will approve the products," Sayer said. "The more we can accelerate technology and offer patients more choices, the better." Because of the thinking on display in the above quote, patients are being sacrificed on the altar of speed. Using substantial equivalence to clear devices for market through the 510(k) process, is not a measure of safety and effectiveness. Patients are nothing more than guinea pigs in this scenario.
In addition, in a study published in JAMA in September, 2017, the author's state that in regards to clinical trials for high risk device modifications, fewer than half of the trialswere controlled, randomized, blinded studies, and the vast majority of the studies used secondary endpoints! This sort of streamlining, harms patients!