One Year Is Not Enough to Harmonize Quality Systems with ISO 13485

On Feb. 23, the U.S. Food and Drug Administration (FDA) issued its long-awaited proposed rule to harmonize its regulations governing current good manufacturing practices (CGMP) for medical devices with international standards. Was it worth the wait? Only time will tell. Meanwhile, here is a briefing of what you need to know about the proposed rule and how it has been received by the medical device industry. The Proposed Rule  In 2018, the US agreed to harmonize its CGMP with agreed-to international standards in accordance with a global initiative called the Medical Device Single Audit Program (MDSAP). In proposing the new rule, the FDA is making good on that promise by revising its Quality System Regulations, part 820, to align with the International Organization for Standardization (ISO) 13485, which the agency says is “substantially similar” to the current US regulations. The basic proposal is to replace part 820 with ISO 13485. However, it is not a simple one-for-one swap. What the FDA is proposing is something of a hybrid of ISO 13485 and key elements of the current CGMP system. FDA Inspection The proposed rule would not affect the FDA’s authority to carry out inspections. The agency indicated that it would […]