The U.S. FDA’s proposal to restructure the Quality System Regulation (QSR) with ISO 13485, the international quality system standard, is a major shift for affected industry, but there are strictly administrative issues associated with this proposal. Several of those who have commented to the docket have expressed misgivings as to the proposed 12-month compliance deadline upon issuance of a final rule.
The FDA’s proposal to harmonize the Quality System Regulation (QSR) with ISO 13485 has finally become more than just a hot topic among device makers, and the agency held a March 2 advisory hearing on the matter. One of the critical concerns for industry is the proposal of a one-year term of implementation upon publication of a final harmonization rule, a timeline that some argue should be doubled or tripled in order to serve as a practicable implementation timeline.
Small American device manufacturers are more likely to sell their products only in the U.S., and thus the FDA proposal to more closely align the Quality System Regulation (QSR) with ISO 13485 would seem to place unwarranted demands on these companies.
The U.S. FDA has at last published what is nominally a draft rule for harmonization of the Quality System Regulation (QSR) with an international standard, ISO 13485, but the draft rule is conspicuous for the absence of specifics.
The FDA’s device center has been eyeing an overhaul of its Quality System Regulation (QSR) for several years, and the latest development is the scheduling of a March 2 advisory committee hearing to review the proposal. The default assumption is that the agency will post the draft rule prior to the hearing, although the routine two-day window for reviewing FDA meeting materials prior to an advisory hearing might leave stakeholders with insufficient time to examine the agency’s proposal.
We’ve been hearing for several years about an FDA proposal to overhaul its device regulatory framework with ISO 13485, potentially the most ambitious FDA undertaking in a quarter century. Those who don’t follow these things might find the subject terminally boring, but such a change could be a massive headache for industry, although it doesn’t have to be if the FDA can get the temperature of this regulatory porridge just right.
The FDA is working toward a rewrite of its Quality Systems Regulation (QSR) and ISO 13485, the internationally recognized quality management standard, but that project has yet to produce a draft rule despite several years of effort. The FDA’s Vidya Gopal highlighted the differences between the two approaches to questions such as management responsibility and staff resources, just two of many differences that will prove difficult to reconcile in any regulatory harmonization effort.
The FDA’s multiyear effort to rewrite the Quality System Regulation (QSR) to align with ISO 13485 could significantly ease the regulatory burden for device makers in multiple markets, but that effort has floundered over the past couple of years. The associated rulemaking is back on the FDA’s agenda, signaling that device makers might soon be able to deploy a single and relatively inexpensive quality management system, which in principle would significantly reduce their compliance costs.
The COVID-19 pandemic’s direct and indirect toll on the human condition is beyond calculation, but the effect on FDA regulatory activity is easier to assess. The problem for device makers is that a number of draft and final guidances are stuck in a pandemic-driven regulatory limbo, which seemingly guarantees that some compliance and product development efforts will run afoul of the agency’s expectations and potentially delay a product’s market access.
Several senior managers at the Center for Devices and Radiological Health (CDRH) have been pushing the convergence between U.S. FDA and international quality systems standards, often with the claim that the two standards already are nearly completely aligned. However, Jack Garvey, CEO of Compliance Architects LLC, ran through a side-by-side comparison of ISO 13485 and Part 820 and maintained that the two standards are too conceptually and textually different to plausibly assert that they are 95% harmonized.