The U.S. FDA’s interest in harmonizing its regulations for medical devices with an international standard is a matter of record, but the agency has found this to be an enormously complicated task. Kim Trautman, executive vice president for medical device services at NSF International, of Ann Arbor, Mich., told BioWorld that the task of rewriting Part 820 to meet ISO 13485 in the middle is no mean feat, but also that it may be delayed again, this time because of the COVID-19 pandemic.

The FDA has posted the harmonization ambition in the Office of Management and Budget’s agenda with a due date of October 2020, although there is no legal deadline. The regulatory agendas for 2018 and 2019 also encoded a reference to the attendant notice of proposed rulemaking, which references ISO 13485, the quality management system standard promulgated by the International Organization for Standardization (ISO). ISO 13485 underwent its most recent rewrite in 2016, a series of changes that most adopting national regulatory authorities took on with a three-year grace period for industrial implementation. ISO recently declared that it would allow the 2016 edition to stand as written despite a proposed rewrite.

Any delay would be ‘completely understandable’

Trautman, who previously served as the associate director for international affairs at the FDA’s Center for Devices and Radiological Health (CDRH), said CDRH Director Jeff Shuren and Melissa Torres, the current associate director for international affairs at the center, have committed to the publication of a draft rule by the end of 2020 in virtual conferences earlier this year.

“I would not be surprised if that October deadline might still be difficult,” Trautman advised, noting that the FDA staff who are responsible for guidance production also are tasked with handling the drafting of changes to Part 820 to interweave elements of 13485. “Under normal circumstances, I would say the people who do that regulatory work … have a very full plate anyway,” Trautman said, but the COVID-19 pandemic is the priority, and thus “if there is a delay, I would say it is completely understandable.”

Trautman said the 95% overlap between Part 820 and ISO 13485 commonly cited by CDRH staff is inevitably a rough estimate, if only because such a comparison requires the parsing of disparate regulatory languages. “To do the comparison [of the two approaches] over the past 20-plus years, you literally had to cut sentences apart” and reassemble them to make the convergence work, a problem encountered regardless of which standard is used as a starting point, she said.

Trautman said that when she was drafting the overhaul of the legacy med-tech good manufacturing practices regulation to form the Quality Systems Regulations (QSRs) in 1996, the thinking at the time was that convergence with 13485 was roughly 90%. The subsequent revision to 13485, which emerged in 2003, boosted that perceived alignment to more along the lines of 93%, but she said the 2016 edition of the ISO standard included some express requirements to work toward more alignment with national regulatory mandates. The list included regulations then in place in several nations, including Brazil, Japan and Australia, as well as the U.S.

The first inspectional framework for the Medical Device Single Audit Program (MDSAP), perhaps one of the more significant accomplishments of the International Medical Device Regulators Forum, was based in part on the 2003 edition of 13485, but also included a few country-specific requirements. A few elements of the MDSAP framework were trimmed after ISO issued the 2016 version of 13485 because they had been written into the ISO standard, and Trautman said consequently, “it’s a good guesstimate that a good 95% of the requirements … are harmonized” between 13485 and Part 820.

CAPA a clunky marriage of functions

One area in Part 820 that the FDA may want to revise is its handling of Part 820.100, the portion of the QSR dealing with corrective and preventive action (CAPA), Trautman said. As the QSR came together at the FDA, ISO had yet to wrap up its work on the first edition of 13485, and thus any eye that was turned toward harmonization had little more than ISO 9001 to examine. At that point in time, 9001 blended corrective and preventive action into one regulatory statement, a move Trautman said perhaps ought to be reversed in the QSR.

There is a considerable amount of commonality between preventive action on the one hand and corrective action on the other, but Trautman said, “this is one area that is ripe for a good overhaul in structuring.” The idea would not be to alter the intent of Part 820.100, but to clarify that measuring and monitoring take place at a number of points in the product life cycle, as well as to provide a bit more clarity as to when an event or signal should be escalated.

Conversely, there are some elements of the QSR the FDA will have to leave as is, in some instances because of certain definitions found in the statute, Trautman said. There is also the classic problem of regulatory entanglement where the various pieces of the regulatory puzzle are concerned, which further limits any aspirations to rewrite Part 820. Wholesale adoption of any language found in 13485 is, as always, not an option because ISO still holds copyrights for its standards. As a result, ISO standards cannot be reprinted in the Federal Register – something that would be required as part of the rulemaking process.

The MSS mess not a showstopper

ISO has expressed an interest in designating 13485 a sector-specific management system standard (MSS), and Trautman said this would come with a requirement that 13485 adopt some language from overarching annexes that are applied to wide swaths of ISO standards. One of the problems in this context is that the annex in question defines risk as a hazard to the organization’s well-being, while 13485 has patients in mind in its definition of risk. ISO will not have to incorporate any such changes into 13485 until the next revision, which Trautman said would not likely arrive before 2024.

Should ISO stick to its guns on this point, it will have several peeved regulatory agencies to deal with, and Trautman pointed out that ISO depends on sales of these standards to fund the organization. Ergo, the problem will have to be resolved in a manner that finds concordance with regulators. Trautman said, “this is something that has been creeping along since 2006,” and hence is of sufficient familiarity that it should not prove insuperable.

Any updates to Part 820 resulting from this harmonization push should not incur much cost for device makers, as most of them are already at least glancingly familiar with the ISO standard. Still, Trautman was reluctant to predict how long it would take the FDA and industry to sort through the comment-and-rulemaking process, assuming the agency meets the October deadline for publication of a draft rule.

Industry will have plenty to say, and there is a need to convene the CDRH good manufacturing practices advisory committee. That hearing will be another forum for industry feedback. Device makers need not fear an FDA steamroller where this change is concerned, Trautman said, because, “I’m confident that this current administration [at CDRH] will do what they can to hear industry’s concerns.”

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