On December 22, 2025, the U.S. FDA updated its list of Recognized Consensus Standards, adding over 100 new and revised entries.

For medical device manufacturers, these internationally developed technical documents (like ISO 14971 for Risk Management, ISO 10993 for Biocompatibility etc.) are more than just guidelines—they are a very efficient path to market. By declaring conformity to these standards, medical device manufacturers provide the FDA with a proven "blueprint" for device’s safety and performance, significantly streamlining the premarket review process. For example, if a medical device manufacturer declares conformity to IEC 62304 (Medical device software — Software life cycle processes), the FDA will review their software documentation vs. IEC 62304 requirements. 

While conformity is generally voluntary (unless "incorporated by reference" into regulation), the FDA encourages using recognized standards to reduce review cycles and ensure consistency.

The latest update includes several standards that are important to software-driven medical devices. 

Few examples:

-AAMI CR515:2025 Cybersecurity Consideration Unique to Machine-Learning Enabled Medical Devices

-ISO IEEE 11073-10472 Health informatics - Device Interoperability - Part 10472: Personal health device communication - Device specialization - Medication monitor

-IEC 80601-2-49 Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors