Medical Device Quality Rules to Match World Norms Under FDA Plan

The FDA is proposing to align its quality standards for medical devices with those used by regulatory bodies across the globe.

The proposed rule (RIN 0910-AH99), released Tuesday, seeks to harmonize standards for manufacturing, storing, and distributing devices, which the Food and Drug Administration says would give patients “more efficient access to necessary devices” and lead to improved quality of life for consumers.

It would revise the agency’s current good manufacturing practice requirements by incorporating a reference to a device quality management standard set by the International Organization for Standardization. Device makers that currently comply with both standards could ...