AAMI News May 2018

Standards Spotlight: International Regulators Seek to 'Optimize' Standards

To further its goal of harmonizing regulatory approaches around the world, the International Medical Device Regulators Forum (IMDRF) has released a proposed document for regulators, standards development organizations, and other stakeholders intended to “optimize standards for regulatory use.”

“This guidance will serve as an educational tool and resource for those involved in standards writing to ensure that standards are useful for the regulatory oversight of medical devices,” wrote IMDRF Standards Working Group Chair Scott Colburn, director of the standards program at the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health, in an email to stakeholders. “It suggests improvements in the standards writing process and recommends best practices for effective regulatory authority participation in standards development that will advance their use for regulatory purposes and ultimately promote the harmonization of regulatory schemes globally.”

Optimizing Standards Content

“All regulators use standards to some degree, but when looking at how they are used, we found great variety in the way regulators approach them,” said Gail Rodriguez, a senior policy adviser at the FDA. “In addition, we found that there are opportunities to improve the way standards are written to make them more useful for reviewing medical devices.”

The IMDRF guidance provides several recommendations so standards will be “crafted in such a way that conformity to them can reduce the burden of regulatory review,” such as:

  • Including a rationale explaining the standard’s general requirements to better clarify the meaning and/or purpose of the standard.
  • Providing “clear and quantitative” acceptance criteria required to demonstrate compliance with the standard.
  • Explaining how conformance can be met in the absence of specific acceptance criteria.
  • Validating acceptance criteria and providing a rationale to support the validation methods.

“It was clear from our discussions that global regulators did not like requirements that did not have clear pass/fail tests or limits,” said Jeffrey Eggleston, a global standards advisor for Medtronic who served as an invited industry representative to the working group. “They also did not like requirements that left things open to the manufacturer’s discretion—anything too heavily risk management based.”

Increasing Regulatory Participation in Standards Development

The guidance also focuses on enhancing regulatory authorities’ participation in the standards development process at both a national and international level.

“Some regulators felt it was very difficult to participate in standards development and that their comments on standards documents were often discounted or ignored,” Eggleston said. “The guidance provides suggestions and information to help regulators participate more fully in the development and revision of standards.”

One such recommendation: Regulatory authorities should enter the process as early in the standard’s life cycle as possible. The earlier that regulators are involved, according to the guidance document, the greater their opportunity to shape the direction of the standard and maximize its “regulatory utility.”

“This guidance sets a foundation whereby members of the IMDRF will be able to participate more effectively in standards development as an organization, as well as improve how IMDRF members work within each of their respective national standards bodies/committees,” Colburn said.

Moving Forward

“It’s a long slow process to harmonize regulatory review (single review among IMDRF members would be the holy grail), but it can’t be done without standards,” Rodriguez said.

That is why it is important for stakeholders to read and comment on the IMDRF document, according to Eggleston.

“The guide isn’t perfect, but it is a good first step,” he said. “With constructive feedback from stakeholders and IMDRF continuing to push global harmonization, this goal can be achieved.”

AAMI plans to submit comments on IMDRF’s proposed document, Optimizing Standards for Regulatory Use. Other stakeholders are encouraged to provide feedback as well. Comments are due no later than May 24. The full text of the document and the comment form can be downloaded from www.imdrf.org/consultations/cons-swg-optimisingstandards-n51-180524.asp.