FDA Reveals Vision for the Transition to ISO 13485

Regulatory NewsRegulatory News | 25 September 2018 |  By 

An apology was offered to device firms during a session at the MedTech Conference in Philadelphia on Tuesday by the US Food and Drug Administration (FDA) over its recently proposed overhaul of the quality system regulation.

“I don’t mean to disappoint,” said William Maisel, chief medical officer at FDA’s Center for Devices and Radiological Health (CDRH). The agency's proposed plans to blend together certain provisions of 21 CFR Part 820 with ISO 13485 through new rulemaking have been public for about a year “so it’s not new, but it’s true that we think this is the right direction to go,” though it may seem scary for those that are just now finding out, Maisel added.

With CDRH in the midst of mapping out the differences and similarities between the two approaches to auditing medical device quality management systems, Maisel currently sees the overlap to be at about 95%. This means there is still 5% “on the fringes that we need to identify and make decisions about how we’re attempting to tackle them,” he said.

Concrete examples of what is being hashed out in the “crosswalk” include medical device reports, the Medical Device Single Audit Program (MDSAP) and unique device identification.

FDA plans to leverage MDSAP for its nationwide adoption of the globally agreed upon standard on device oversight as the audits are conducted against 13485 under this program.

The transition aims to provide greater consistency and predictability in CDRH’s inspection program by shifting away from being risk-based toward a for-cause approach. This, in turn, is intended to be a major driver of modernization and global harmonization of device regulations.

The accumulated total of manufacturing sites that have joined the international auditing program that is MDSAP, which is a product of the International Medical Device Regulators Forum, has substantially increased since it first became operational in 2014 with just four participants.

MDSAP’s participation growth is depicted in the graphic below.

The current total of 2,629 sites worldwide, compared to the 1,749 total CDRH previously reported, indicates that MDSAP has continued to gain interest from firms seeking the time and cost saving benefits associated with meeting requirements in various jurisdictions.

The graphic also shows that well over 50% of the MDSAP participating manufacturer sites are located in the US, with Canada, Germany, Japan and China rounding up the top five.

In Canada, MDSAP certificates will be required for firms to legally market medical devices and technologies in the country as of early next year. Yet the transition has presented several challenges, particularly for small- to medium-sized device firms with a presence in Canada.

Issues reported in a survey conducted earlier this year include “long wait times to schedule audits and receive audit results or certificates, despite MDSAP program guidelines that require adherence to specific timelines.” The survey results were shared in a July letter to FDA, copying Health Canada, that suggested potential solutions to improve the auditing program.

CDRH, meanwhile, intends to roll out its revised quality system regulation by April 2019. In an attempt to ease the concerned faces among audience members, Maisel stressed that there will be a public comment period after each step in the process to adopt the rule proposed in May.

Further, the agency likely began thinking about how to leverage the MDSAP framework for its proposed regulatory overhaul while it was “heavily involved” in the development of the last version of 13485 from 2016, argued Terumo’s director of quality systems Mike Silvestri. Greater alignment is needed in the program and should be provided in a single document, he added.

Other remaining barriers to MDSAP growth in the US relate to a lack of an established pathway for device-led combination products, as well as confusion among participants over what requirements are applicable, attendees at the AdvaMed conference session noted.


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