Late in February 2018, the FDA announced that as part of global harmonization efforts around quality management systems, the agency is considering adding clauses from ISO 13485:2016 to the appropriate US medical device quality regulatory requirements.
FDA press officer Stephanie Caccomo stated via email:
“With the publishing of the 13485:2016 revision, there has been industry evaluation of the regulatory requirement linkages to the standard. In the spirit of global harmonization of quality management systems, the FDA is considering an evaluation/mapping of the 13485 clauses to the appropriate U.S. regulatory requirements.”
FDA then published a rule in Spring 2018, stating:
“FDA intends to harmonize and modernize the Quality System regulation for medical devices. The revisions will supplant the existing requirements with the specifications of an international consensus standard for the medical device manufacturer, ISO 13485:2016. The revisions are intended to reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements. The revisions will also modernize the regulation”.
The FDA 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 “reduce compliance and recordkeeping burdens” related to quality system regulation requirements.
The proposed FDA rule for harmonizing medical device quality management systems with ISO 13485 is “an important next step,” an International Organization for Standardization (ISO) committee said in a post Monday, August 27. The move forms part of a larger push for global regulatory harmonization, including via the Medical Device Single Audit Program. The global standard is used as the foundation for implementation of the auditing program across multiple jurisdictions. 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 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 less cost and an easier time aligning their compliance to enter the US market.
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