On Feb. 23, the U.S. Food and Drug Administration (FDA) issued a proposed rule to harmonize its good manufacturing practices (CGMP) regulations for medical devices with International Standardization Organization (ISO) 13485. The basic proposal is to replace the current Quality System Regulations, part 820, with ISO 13485. But it’s not a straight one-for-one swap.
For one thing, the FDA would retain authority to carry out inspections. The agency indicated that it would modify its current approach to ensure that the inspections it carries out are faithful to the international requirements. However, the proposal doesn’t offer any specifics about what that changed approach might be. This lack of detail will make it challenging for companies to prepare for inspections under the new rule. The proposed rule would also retain current part 820 requirements for device labeling and packaging operations, issues that ISO 13485 doesn’t address.
If the rule is finalized, it will take effect on February 23, 2023. While generally supportive of the proposal, industry contends that manufacturers need more time to fully understand the changes, revise their IT systems, redesign their existing quality systems, and retrain their employees.
Learn more in the April 2022 issue of Diagnostic Testing & Emerging Technologies.