FDA Recognition of ISO 14971:2019 as a Consensus Standard

ISO 14971, which defines risk management requirements throughout the medical device development lifecycle, is widely recognized as an international standard for medical device regulation. As of January 2024, the FDA formally recognizes ISO 14971:2019 as a Consensus Standard, a designation with significant implications for medical device manufacturers submitting regulatory submissions such as 510(k) and Premarket Approval (PMA) applications.

Regulatory Authority Recognition and Transition Schedule

The FDA’s formal recognition of ISO 14971:2019 as a Consensus Standard means that medical device manufacturers are now required to demonstrate compliance with ISO 14971-based risk management systems in their regulatory submissions. However, a transition period has been established through regulatory consensus agreements.

Specifically, the 2007 version of ISO 14971 had been acceptable in regulatory submissions until December 25, 2022. During this transition period, previously submitted or ongoing submissions were permitted to reference ISO 14971:2007. However, for any new regulatory submissions made on or after December 25, 2022, compliance with ISO 14971:2007 is no longer acceptable, and submissions must demonstrate conformance to the 2019 version or later.

Background: Key Changes from ISO 14971:2007 to 2019

The ISO 14971:2019 version incorporates several important improvements designed to make medical device risk management processes more systematic and transparent. Notable enhancements include clarified methodologies for risk assessment, more rigorous requirements for risk control effectiveness verification, and strengthened post-market risk monitoring procedures. These improvements enable more robust risk management throughout the entire medical device lifecycle.

The FDA and other regulatory authorities continuously update their guidance documents and regulatory expectations in response to the evolution of international standards. Medical device manufacturers must remain attentive to these international regulatory developments to ensure ongoing compliance.

Recommended Actions for Applicants

Organizations planning regulatory submissions for medical devices should consider the following points. First, for submissions currently in progress, existing submission strategies may not require modification; however, new submission plans must be developed with full compliance with ISO 14971:2019 as a prerequisite. Second, companies considering international expansion should verify the latest requirements not only from the U.S. FDA but also from other regulatory authorities including the European Medicines Agency (EMA) and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, and should evaluate the alignment of regulatory requirements across different jurisdictions.

Detailed information is available in the FDA’s recognized standards database: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=40369