What is the FDA recognition number for IEC 62304?

13-79: IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION.

FDA-recognized standard · Software/Informatics

IEC 62304: Medical device software - Software life cycle processes

Yes. FDA recognizes IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION as recognition 13-79, entered 2019-01-14.

FDA recognitions of IEC 62304, newest first (FDA database snapshot of 2026-09-01)
Recognition	Edition	Entered	Extent	Transition ends
13-79	IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION also ANSI AAMI IEC 62304:2006/A1:2016	2019-01-14	Complete	—

No product code cites IEC 62304: it is a horizontal standard, applied across device types rather than tied to particular codes.

Source: FDA Recognized Consensus Standards database, snapshot of 2026-09-01. Search every recognition in the Consensus Standards Lookup, or browse all standards with a page.