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Implementation Timelines a Key Concern Regarding FDA Proposal to Align with ISO 13485, BioWorld MedTech

Tuesday, May 24, 2022

The Food and Drug Administration’s (FDA’s) proposal to restructure the Quality System Regulation (QSR) with International Organization for Standardization (ISO) 13485—the international quality system standard—is a major shift for affected industry.

But there are administrative issues associated with this proposal. Partner Dennis Gucciardo told BioWorld MedTech that in addition to comments by the industry, there is also the question of how the FDA will react when ISO next updates 13485. Dennis said that many observers were surprised at the FDA’s harmonization-by-reference approach rather than a rewriting of Part 820—a method that carries its own risks, including the task ahead of the FDA next time 13485 is updated.

Despite these apprehensions, Dennis noted, “the support for harmonization comes from across companies that do business in the US, including companies that are headquartered in the US. Most of the comments to the docket support that view, and thus, ‘there is too much forward momentum for this thing to die,’ he said.”

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