FDA Forecast and Analysis for 2019

Get ready for “increased product complexity and risk aversion” from the FDA. It’s top regulators, says regulatory attorney Mark DuVal, “disdain” the 510(k) clearance program and are intent on sweeping changes which, they hope, will modernize the device clearance system.

That’s DuVal’s prediction. After decades of representing medical device companies and having had his share of negotiations with the FDA, it’s a prediction worth noting.

DuVal walks a fine line. On one side he has to advocate for his medical device clients. On the other, he has to please FDA regulators for those clients. The life of a device company can hang in the balance. Just ask the folks at ReGen Biologics or CoAxia.

What will that more complex and risk averse fine line between device companies and the FDA look like in 2019?

On November 26, 2018, we got a hint when FDA Commissioner Scott Gottlieb, M.D. and his Center for Device and Radiological Health (CDRH) Director, Jeff Shuren, M.D. announced plans to formally propose a major overhaul of the 510(k) process. Eighty-two percent of all medical devices reach the market under the 510(k) pre-market notification rules of the FDA.

“Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies,” said a joint statement by Gottlieb and Shuren.

The duo is now seeking public feedback on whether predicates older than 10 years are still relevant and if the Agency should act to “advance the use of modern predicates.”

They gave the public until March 7, 2019 to comment.

DuVal Unplugged

DuVal didn’t wait—or hold back.

In a note to his clients on December 18, 2018, DuVal predicts there will be an attempt to create a new 510(k) program.

He noted Gottlieb and Shuren’s “firm belief” in the merits of the program, BUT said the program needs a “new framework.” He also reminds his readers of Shuren’s inaugural and failed attempt to rewrite the 510(k) program in 2009 when he asked the Institute of Medicine to propose recommendations to rewrite (or even abolish) the 510(k) program. That attempt was met with a huge industry counter-movement.

The framework now being considered would eliminate the use of predicates older than 10 years. The agency also wants to publish a list of newly cleared devices which use the older predicates. Essentially, says DuVal, the FDA wants to publicly “shame” the makers of those devices.

The Agency, writes DuVal, also wants to create a new, as yet undefined, alternative pathway to clearance.

“The Agency does not seem to realize that there is nothing wrong with older predicates and that the predicate family updates itself through innovation. FDA seems to want to involve itself in influencing the medical marketplace to make decisions about which devices to use or not.” Where does the agency get the authority to make these changes, he asks rhetorically.

“This seems to be a solution in search of a problem. Industry is fatigued keeping up with Dr. Shuren’s endless proposals to ‘update’ the 510(k) program over his tenure. It has caused endless and unnecessary turmoil.”

“The 510(k) program isn’t perfect, but it works, and everyone is familiar with it. It isn’t a race horse, it’s a plow horse. It isn’t fast or sexy, but it gets the job done.”

‘The problem is the FDA is getting increasingly academic and wants to change it either out of regulatory boredom, fiefdom building, or both. The one guy who really knows how to honor and apply the 510(k) program is Dr. Maisel, Director of the Office of Device Evaluation and Chief Scientist, CDRH.”

The industry, adds DuVal, needs to remind the FDA they are an administrative organization, not a legislative body. “If they want to make some of these changes, like the 510(k), they will have to propose them to the Congress.”

Lowering Device Risks

The FDA, writes DuVal, will become more risk averse as new young biomedical reviewers “continue to see boogeymen in every closet.”

For instance, DuVal says that when there is a “rare event” with a product, the FDA tries to over-regulate the 98% of products that will likely never experience the problem.

“In an attempt to be architects of regulatory perfection,” DuVal writes, the FDA begins to require so much information upfront that innovation is stifled. And the risk aversion is not limited to device submissions, it impacts post-marketing requirements, FDA inspections, etc., as well.

He points out that devices don’t have the big profit margins as drugs, and if more testing and post-marketing requirements are imposed, “we will stifle the introduction of new innovative products.”

Add in new documentaries like Netflix’s “The Bleeding Edge” and reporting by the International Consortium of Investigative Journalists (ICIJ) covering medical device stories on implantable devices, “you get a perfect storm for the request for new, over-reactive laws and regulations.”

One of those stories described how six medical devices (two of them orthopedic—spinal cord stimulators and hip prosthesis) out of more than 190,000 were responsible for a quarter of all the medical-device-related injuries and deaths reported to the FDA from 2008 to 2017.

“These perceived ‘crises’ give FDA (and the plaintiffs’ lawyers) political cover to ask for more regulation.”

Open Mini-PMA?

He says because of their “disdain” for the 510(k) program the FDA would rather have an open mini-PMA standard. “It does not like being tethered to the standard of establishing safety and effectiveness in a comparative sense to another predicate. FDA would rather have a standard of (re-)establishing safety and effectiveness in an absolute and independent sense.”

With that standard, DuVal says, the FDA can ask for any amount of data it wants. “FDA should take into account what it already knows about a given device, predicate family, technological platform, and/or material, etc. The idea behind a predicate is precedence, i.e. not unnecessarily re-inventing the wheel, or asking for data on what is known and can be scientifically extrapolated.”

He concludes: “Think of the myriad of post-marketing requirements that have been put into place or are coming, not by law or regulations, but by FDA guidance. It is an avalanche of (over-)regulation.”

Here Comes the Office of Product Evaluation and Quality

Jeff Zumhofe, a quality system consultant featured in DuVal’s note, says the CDRH launched pilots in 2018 of its Total Product Life Cycle (TPLC) approach across the organization and will continue to push for those changes in 2019. Full implementation of the restructuring plan is anticipated in early-mid 2019 after approval by FDA, HHS and Congress.

A big deal is the planned change to merge the Office of Compliance, Office of Device Evaluation and Office of Surveillance and Biometrics into one “Super Office,” the Office of Product Evaluation and Quality (OPEQ).

OPEQ will consist of three offices: Office of Health Technology (OHT), Office of Clinical Evaluation and Analysis (OCEA), and the Office of Regulatory Programs (ORP). CDRH will organize along product category groupings intended to better facilitate access to product lifecycle data and thereby improve efficiency and collaboration.

The ORP will have responsibility for submission support, establishment support (registration and listing, audits, and FDA inspections), and market intelligence (complaints, MDRs, recalls, product shortages).

Zumhofe tells clients to be aware that the Office of Medical Device and Radiological Health Operations (OMDRHO) within ORP has established three geographically defined Divisions, and the previous line of follow-up with the local District has now been shifted to the appropriate Division contact. 

Value, Digital Health and Wellness Device Regs

Beth Luoma, an associate attorney with DuVal, writes the shift from fee-for-service to value-based care will continue. She says manufacturers are going to have to demonstrate that their value proposition “actually plays out” in “creating value-based arrangements with customers that appropriately share risk but fall within the current legal and regulatory framework for discounts and warranties under the Anti-kickback Statute.”

Digital Health, writes Lisa Pritchard, a regulatory, quality and compliance consultant, “is likely to see a radical innovation explosion in the coming months, particularly in the areas of mobile applications, artificial intelligence, augmented reality, and cloud-based processing.”

“The challenge will be in effectively partnering with FDA to manage the data expectations to allow these new types of products to efficiently make it to commercialization.”

The growth in the design and use of Mobile Medical Apps (MMA) will be a significant challenge for companies not typically used to interpreting medical device regulations. She adds that there will be a requirement for Quality Management Systems to ensure appropriate controls through the life cycle of product claims.

DuVal associate attorney, Aaron Hage, writes the 21st Century Cures Act and FDA’s Final Guidance, “General Wellness: Policy for Low Risk Devices” have provided a safe haven for products intended to only be used for general wellness purposes, and not for the cure, mitigation, treatment, or prevention of disease.

Manufacturers have taken advantage of this statutory exemption to create devices that allow people to take a more active role in their own wellness decisions. “However, many of these technologies have advanced to include diagnostic capabilities and claims, and thus have moved back into FDA’s realm of regulation and oversight.”

He warns the Agency may decide to step up its enforcement powers on those wellness products “that may meet the definition of a medical device but do not fit the defined boundaries of its enforcement discretion.” Manufacturers will have to decide if they want to stay on the wellness product side of the line and be safe from prosecution or decide to compete with more sophisticated technology and comply with regulations to have the marketing advantage of claiming FDA clearance or approval.

Commercial Speech and Marketing

The FDA is likely to pay closer attention to how product information is being communicated to audiences, states the DuVal note. If a company shares truthful scientific information not on the product’s label, that company and its employees have been subject to criminal prosecution.

Luckily, courts have stepped in to protect the right of sales reps and companies who share such information and the FDA has acknowledged there is a problem with their current position. But the issue remains unsettled.

DuVal writes the FDA will likely continue to struggle with the line of demarcation between its right and desire to review commercial speech and the constitutional limitations placed on the Agency’s authority by the First Amendment.

He expects that line to be tested and challenged by both FDA, industry, and various advocacy groups. “FDA will continue to struggle to find a proper balance between protecting patients and physicians from information that it has not reviewed and approved with the paternalistic temptation to suppress the free exchange of medical and scientific information, in whatever format or venue it is created and communicated.”

This will be an interesting year, concludes DuVal. “We’ll see if AdvaMed and MDMA [industry trade associations] protect the industry from debilitating change.”