CDRH Proposes New IMDRF Work Item on Standards

Regulatory NewsRegulatory News | 26 March 2019 |  By 

Medical device industry delegates and global regulatory authorities are looking to further support their collaboration with standards development organizations (SDOs) through a newly proposed liaison program.

Scott Colburn, director of the standards program at the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH), pitched an International Medical Device Regulators Forum (IMDRF) new work item (NWI) during a workshop hosted by the IMDRF standards working group and the Global Diagnostic Imaging, Healthcare IT and Radiation Therapy Trade Association (DITTA) last week in Russia.

The NWI proposal (NWIP) seeks to set new parameters for IMDRF to serve as liaison to the International Electrotechnical Commission (IEC) and the International Organization for Standardization (ISO). It comes after IMDRF became liaison to ISO TC210—the working group on ISO 13485—and to IEC TC 62 last year.

According to Colburn, the SDO liaison program that would be established if the NWIP is granted by the IMDRF management committee (MC) would allow for effective representation in liaised SDO committees and working groups and support multilateral communications to “foster and convey consensus among IMDRF members to establish positions of regulatory importance to share with SDOs.”

Colburn, who also serves as chair of the IMDRF standards working group, reported the NWIP as being under the IMDRF MC’s consideration. The NWIP drew support from several others at the IMDRF-DITTA workshop in Russia to encourage strong and growing relations with SDOs.

The NWIP for an SDO liaison program garnered the support of DITTA as well as that of IEC and ISO, with ISO/TC 210 committee chair Peter Linders noting that “obviously, IEC and ISO demand a ‘standard approach.’” To operationalize the IMDRF liaison to ISO and IEC, Linders argued for three critical elements: the NWIP, stakeholder representation and a convener. The NWIP “reflects clear vision of [the] intended deliverable, has solid justification for the effort to be made” and is “realistic about time needed,” according to Linders. He recommended using select IMDRF “essential principles.”

The IMDRF standards working group was established with the goal of enhancing the use of standards for harmonized approaches to medical device regulations on a regional and national level.

The efforts of the IMDRF standards working group, which is comprised of all 10 IMDRF regulators, DITTA and the Global Medical Technology Alliance, are aimed at reducing the burden associated with meeting or enforcing set regulatory requirements.

The use of standards provides an opportunity for manufacturers to seek compliance in certain areas across multiple jurisdictions. Regulators can leverage standards to achieve review efficiencies using standardized conformance assessments. For SDOs, benefits relate to greater assurance of recognition by regulators.

To harmonize regulators’ approaches to the use of standards, current objectives of the IMDRF standards working group include increased and enhanced regulator influence in standards development processes and analyzing approaches to using standards in regulatory reviews of medical devices. A cornerstone of this harmonization work involves recommendations for developing standards of regulatory grade. New recommendations to regulators and SDOs were established last November in a final technical document.

“Standards play a significant role in the design, production, post-production and regulation of medical devices throughout their lifecycle,” said CDRH associate director for international affairs Melissa Torres.

The IMDRF standards working group’s current work item seeks to harmonize regulatory authorities’ (RAs) use of standards by comparing recognition and use policies and developing a checklist of commonly recognized standards.

“Preliminary analysis shows broad commitment to use of standards but differing policies and programs: mostly in how RAs’ approaches are,” Colburn reported. He added that a report on results from the working group’s survey on RAs’ use of standards will be submitted to the IMDRF MC in September.

The preliminary results shared during the IMDRF-DITTA workshop pointed to other challenges in how IMDRF RAs use standards, including varying frequency of updates to lists of recognized standards.

Linders also provided an overview on the future of the international standard for medical device quality management systems, known as ISO 13485, for which industry completed a transition to the revised 13485:2016 last month. The 2016 version of the standard is to undergo a systematic review for conformity to the ISO High Level Structure (HLS) next month. The systematic review was delayed from its original February schedule, following pushback from the IMDRF Medical Device Single Audit Program, due to potential ripple effects of revisions to terms and definitions. It would been problematic for the review to occur during transitional deadlines, the consortium argued.

The likelihood of the upcoming 13485:2016 HLS revision resulting in “substantive change is minimal,” said Linders. The target effective date for the HLS-revised standard is 2022. Linders provided an additional overview of changes to ISO 1471:2019, which standardizes a risk management framework.


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