International investigation links 1.7M injuries to medical devices, as FDA moves to reform its 510(k) process

  • December 04, 2018

The series of stories published in November 2018 across several outlets details the patchwork of international regulatory regimes overseeing the medical device industry, finding products being marketed with little to no human testing, or devices pulled from sale due to safety concerns in some countries while still being sold in others.  For example, the U.S. issued over 26,700 device recalls during that 10-year period, while India issued only 14 from 2013 to 2017.  To centralize that information, the ICIJ built the first international public database of more than 70,000 device recalls, safety alerts and field safety notices gathered from 11 countries.

Of the more than 4,000 types of devices listed in the FDA’s data, six accounted for about 25% of the injury reports: hip prostheses, insulin pumps with sensors, implanted insulin pumps, spinal stimulators, surgical mesh and defibrillators, according to the Associated Press, which participated in the investigation. Other high-profile devices have included contraceptive coils and breast implants.

The day after the reports were published, the FDA outlined plans to modernize its 510(k) clearance program, which covers the large majority of the agency’s device reviews — including plans for additional safety and performance criteria, as well as a push to urge manufacturers to use more recent predicate devices as the basis for their submissions.

“We believe firmly in the merits of the 510(k) process” first established in 1976, FDA Commissioner Scott Gottlieb, M.D., and CDRH Director Jeff Shuren, M.D., said in an Agency statement.  “But we also believe that framework needs to be modernized to reflect advances in technology, safety and the capabilities of a new generation of medical devices.”

Under the 510(k) pathway, manufacturers compare their products against previously cleared predicate devices to demonstrate that they are just as safe and effective.  However, older predicates may not reflect the modern tech in new devices and other advancements.

The FDA said its data showed that nearly 20% of current 510(k) clearances are based on predicates over 10 years old.  In 2017, CDRH cleared 3,173 devices through the pathway, totaling 82% of all devices cleared or approved.

“To be clear, we don’t believe devices that rely on old predicates are unsafe, or that older devices need to be removed from the market,” Gottlieb and Shuren said.  “However, we believe that encouraging product developers to use more modern predicates would give patients and their doctors a choice among older and newer versions of a type of device, promote greater competition to adopt modern features that improve safety and performance, and help make sure that newer devices reflect more modern technology and standards that can improve patient care and outcomes.”

As a result, the agency believes more manufacturers will opt for the de novo review pathway.  In the coming weeks, the FDA plans to propose a rule clarifying the requirements and procedures for de novo submissions.  In addition, the Agency plans to finalize its guidance early next year on an alternative 510(k) pathway allowing the use of objective safety and performance criteria to show equivalence in well understood device types.

In mid-November 2018, before the ICIJ’s investigation was published, the FDA committed to being “consistently first” among international regulatory agencies in responding to medical device safety signals.  The Agency said it has begun transitioning to an active surveillance system using real-world evidence and plans to seek new authority to take faster post-market regulatory actions.  In addition, the FDA pointed to increased inspections of medical device manufacturers over the past decade, especially overseas.  “Our increased oversight has led to tangible results with improved compliance,” Shuren said in a statement.  Since 2007, annual numbers of device inspections have increased 46%, while inspections of foreign firms have increased 243%.

In a statement responding to the agency’s 510(k) changes, the U.S. medical device lobby the Advanced Medical Technology Association, also known as AdvaMed, said that while the pathway has proven to be effective over the years, it’s a process that can be improved.

“FDA acknowledges that its concern with older predicates only applies to a minority of devices and that those devices have no demonstrated safety concerns,” said AdvaMed CEO Scott Whitaker.  “It is our hope that through the regulatory review, the Agency will recognize that in some cases there are legitimate reasons for using older predicates, and that for some devices where the technology has changed little using those older predicates still makes sense.  The proposed 10-year cut off criteria could prove arbitrary as older predicates can offer extensive data about their performance, which helps sponsors introduce newer, safer devices.”

AdvaMed’s response to the ICIJ investigation; however, stressed that medical devices form the foundation of modern medicine.  “Yet, instead of a comprehensive look at both the challenges and the achievements of an industry that touches almost every human life, these stories counterfeit the life-changing and lifesaving solutions delivered to billions of people worldwide,” Whitaker said. “We should never discount any patient’s experience. But by magnifying the stories of only a few individuals, we overlook the overwhelmingly positive experiences of millions of others.”

MedTech Europe, which represents the industry in the EU and Brussels, pointed to the strict regulatory environment the industry operates under.

“The ICIJ investigation shares the same fundamental belief that it is important to provide products that work and are safe,” it said in a statement.  “Its perspective, however, on how the industry works does not align with ours.”

REFERENCE:  Fierce BioTech; 26 NOV 2018; Conor Hale

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