Ahead of the proposed shift away from the current US Food and Drug Administration (FDA) quality management system (QMS) CFR 21 Part 820 regulation toward ISO 13485:2016, a new white paper sheds light on how the action will impact medical device development.
The white paper identified three interrelated principles that will define the direction of the agency’s process, which has yet to be clearly defined, after the transition
. These principles relate to the concept of safety by product design, FDA’s safety/effectiveness gold standard and least burdensome principles.
“FDA is more likely to enact changes that promote, maintain or improve safety and effectiveness for users and patients that do not result in significantly more burden for both themselves and the industry,” according to the white paper from Massachusetts-based software firm Cognition Corporation. “More explicit requirements for design controls might fall under this umbrella, and therefore need to be understood as a real concern for manufacturers to prepare for.”
The standard was revised with the total product lifecycle (TPLC) approach in mind. As such, FDA is expected to expand on risk management regulations to better incorporate the TPLC vision.
Cognition issued the second white paper of its two-part series Tuesday on the impact of the transition from FDA’s regulations to the globally-agreed upon standard for medical devices quality management systems. The first white paper from January largely focused on major changes to previously harmonized requirements that the 2016 revision of the International Organization for Standardization (ISO) standard introduced, whereas the second white paper is specifically targeted at the correlation between FDA’s regulation and ISO 13485:2016.
Both white papers were developed based on an analysis of the old and the revised versions of ISO 13485 as well as the text of CFR 21 Part 820, authored by NSF International’s executive vice president of medical device international services Kim Trautman while employed by FDA. Trautman previously told Focus
each subsequent version of 13485 brought greater convergence of regulations, particularly the 2016 edition, and FDA “has the right intention” to continuing driving the trend via the shift.
Cognition’s second white paper comes just as device manufacturers completed
their reportedly smooth three-year transition
for 13485:2016 compliance across the world, including in Canada, Europe, Australia and the US. In light of this transition, the white paper seeks to ease concerns on another just around the corner.
Many clients reached out to express their concerns around the harmonization initiative that was set in motion as part of the agency’s 2018 fall agenda
for proposed and final rulemakings, Cognition content creator Nick Schofield told Focus
Schofield, however, joins others like Trautman in spreading the word for industry not to fret over the agency’s regulatory shift. This is partly because FDA’s regulation mirrors various clauses of the standard and vice versa. The overlap is at about 95%, FDA Center for Devices and Radiological Health (CDRH) chief medical officer William Maisel estimated
during AdvaMed’s 2018 MedTech Conference last September.
A new technical information report (TIR) is underway at the Association for the Advancement of Medical Instrumentation (AAMI) to map the ANSI/AAMI/ISO 13485:2016 and 21 CFR 820 correlation. Comments from a ballot opened on Monday will be incorporated in AAMI TIR102, Wil Vargas, secretary of the ISO technical committee (TC) 210, told Focus
. Vargas, who also serves as AAMI’s director of standards, added AAMI TIR102 is expected to be published this summer. FDA plans to publish its proposed rule by this September.
In the meantime, the new white paper adds to the growing consensus on the anticipated plans for the transition. It echoes others, including AAMI
and NSF International
, in predicting both the process for the transition and the intended results. FDA’s move will place greater emphasis on risk management from a TPLC perspective as well as documentation control, Schofield said.
Those with 13485:2016 compliance certificates are in a better position for the shift. But this should not lead to a “free-for-all,” Schofield argued. There is still time to leverage emerging solutions based on a company’s size, its needs and its future plans. From the agency’s TPLC push
to those for harmonization
, Schofield noted an array of CDRH initiatives already underway that set the scene for the future regulatory landscape post transition. He further argued manufacturers should look to the recent CDRH initiatives
and guidances, including those on least burdensome principles
and premarket cybersecurity
, to get a better sense of what to expect.
It is better to act sooner rather than later, Schofield added. Failure to complete the transition to the International Medical Device Regulators Forum (IMDRF) Medical Device Single Audit Program (MDSAP) as of 1 March resulted in the termination
of some medical device licenses in Canada’s market. FDA plans to leverage MDSAP to roll-out the transition prior to nationwide adoption of the harmonized regulation.
The 13485:2016 systematic review has been initiated on an expedited
schedule by ISO to consider revising the standard to conform to the ISO High Level Structure (HLS). “National bodies have been sending letters to TC210 expressing support to not institute any changes to the normative text at this time,” said Vargas. “ISO/TC210 has established an ad-hoc task group to participate in the ISO task force looking into revising the overall HLS and understand the precise technical impact the HLS would have.”
Cognition concluded that FDA “will more likely pick and choose elements to harmonize with, dependent upon factors such as feasibility, applicability, and need." This would stand regardless of the 13485:2016's upcoming revision to conform to the HLS, said Schofield.