In recent years, the US medtech industry has wrestled with a way to ease compliance with the U.S. Food and Drug Administration’s Quality System Regulation Process Validation. The industry has called for FDA to make it easier to parse the similarities and differences between the agency’s Quality System Regulation (QSR), 21 CFR Part 820 (Subchapter H – Medical Devices) and the voluntary standard (but de facto business requirement), ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes.”
The news came on February 23 when FDA issued a new Proposed Rule: Quality System Regulation Amendment. In an accompanying announcement, the agency said:
“The FDA seeks to harmonize its requirements for a Quality Management System (QMS) with internationally recognized regulatory requirements for Quality Management System (QMS) for devices, ISO 13485, which is used by many other regulatory authorities.”
If finalized, the ISO 13485 standard will be incorporated into the regulation with additional added requirements to ensure consistency and alignment between ISO 13485 and existing requirements in the FD&C Act and its implementing regulations, according to the agency. (See this chart from 13485store.com for a side-by-side comparison comparing ISO and FDA quality systems.)
The FDA-ISO convergence is no mere rewrite of the regulation but a wholesale replacement that could prevent misinterpretations that can slow validations both pre-market and through production, if an FDA inspector issues an FDA Form 483 letter or “inspectional observation,” which can cost thousands or millions of dollars in penalties, reworks, scrap, line shutdowns, and much worse with regard to patient health.
There’s still some wrangling as to how to manage inevitable changes including those to the standard. At present, “2016” is the current edition of the standard, which is reviewed for possible updates every five years.
Your Injection Molder's Quality Requirements Are Your Own
The current edition of the standard includes a more explicit requirement than prior versions requiring medical device manufacturers and their injection molders to not only establish and maintain a quality system but to meet all applicable regulatory requirements. ISO currently reports that 13485:2016 “can also be used by suppliers or external parties.”
That “can” is on the way to becoming a legal “must.” But in any eventuality, you and your injection molder (including Crescent Industries) must continue to maintain and update FDA registrations, audits, and certifications you require including 21 CFR Part 820 to ISO 13485:2016 QMS.
In turn, your efficient and effective validation will continue to require supplier competencies such as product risk management, CAPA (corrective and preventive action), design change control, root cause analysis, complaint handling, and nonconformity response. Additional, overarching competencies pervade compliance and validation efforts: document control and proper employee training to all requirements.
The right blended of team competencies, collaboration, and quality culture should yield the confidence to trust – and verify – that your supplier will help you guide your validation smoothly through project kickoff; DFM (design for manufacturing) and mold design/fabrication; process development and validation; sampling and FAIRs, or first-article inspection reports; and transition to the production of your fully validated product.
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