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ISO Preps for FDA’s Proposed Overhaul of Device Quality System Regulation

A lately proposed US Food and Drug Administration (FDA) rule for harmonizing medical device quality management systems with ISO 13485 is “an essential next step,” an International Organization for Standardization (ISO) committee said in a Monday post.

Plans for the new rulemaking have been the subject of widespread debate since at least February when FDA spokesperson Stephanie Caccomo told Focus the agency “is considering an evaluation/mapping of the 13485 clauses to the appropriate U.S. regulatory needs.”

The agency seeks to blend the third iteration of the international consensus standard for quality management systems with 21 CFR 820 as part of an effort to “decrease compliance and recordkeeping burdens” related to quality system regulation requirements, according to FDA’s rule.

The move forms part of a larger push for international regulatory harmonization, including via the Medical Device Single Audit Program. The international standard is used as the foundation for implementation of the auditing program across multiple jurisdictions.

The proposed rulemaking is “an important next step in the recognition” that 13485 “has already gained internationally,” said Barnaby Lewis, digital communication specialist at ISO.

Yet implementation of the proposed revisions is expected to be an uphill battle for FDA as it continues to grapple with the rapidly-changing device sector in the US.

In March, the Association for the Advancement of Medical Instrumentation said it plans to work in collaboration with FDA to “develop a technical information report that will cross reference 21 CFR 820 with ISO 13485:2016 and vice versa.” The group was charged with administering the US advisory group that participated in the development of the latest version of 13485 from 2016.

In addition to reduced regulatory burden, harmonization is expected to play a role in attracting a greater number of device companies to the US.

"In theory, a company that is compliant with ISO 13485 outside the US should have an easier time and cost less to align their compliance to enter the US market," Wil Vargas, director of standards at AAMI, told Focus. The new rulemaking, therefore, may support "more companies to more easily" bring their products to the US, Vargas added.

 

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