In its continued efforts to harmonize with international regulatory authorities, the U.S. Food & Drug Administration has an nounced its intention to amend the current good manufacturing practice requirements of the FDA quality system regulation, 21 C.F.R 820 et seq. to align more closely with the international consensus standard for devices, ISO 13485. This is the first signifi cant change of this type in 26 years.
The FDA is proposing to converge the existing FDA quality system regulation with ISO 13485, (2016 edition). This voluntary consensus standard set by the International Organization for Standardization in Switzerland has long been used by interna tional device companies and device servicers as the foundation for many countries’ QMS requirements. ISO auditor Julie Mardikian noted in this regard: “ISO 13485 relies upon a process approach to quality management and this approach should be applied whenev er possible.”
The FDA proposed adoption, as reported in the Federal Register, provides that the proposed FDA rule would not be a blanket substitution. Rather, FDA would incorporate the standard with some of the existing requirements in the Federal Food, Drug, & Cosmetic Act. The purpose of the regulation, as acknowledged by the FDA is to provide “more efficient access to neces sary devices …” Jason Kitchell President of Universal Medical Resources, Inc. acknowl edged its benefits: “We have found our ISO 13485 program to be an excellent manage ment tool for both customer expectations and for employee training. It’s an ongoing process and we continue to strive to improve.”
The FDA is providing an opportunity for comment, either electronic or written and in this connection, has set the deadline for submission of electronic comments to be May 24, 2022. Comments may be sent to the federal rulemaking portal at https:// www.regulations.gov.
SIMILAR TO EXISTING QMS REGULATION
The FDA noted that the ISO quality management system requirements, when taken in totality are, substantially similar to the requirements of 21 CFR Part 820. The FDA further acknowledges that ISO 13485 requires a similar assurance of a companies’ quality management system. As part of its efforts to harmonize the FDA quality system regulation, the FDA proposes to withdraw some of the requirements in the current part 820 but retain the scope of the QMS regulation and retain/modify the current regulation in order to address among other things the QMS definitions in Part 820. The FDA also seeks to clarify certain concepts in ISO 13485.
WHAT ARE THE PRACTICAL EFFECTS EXPECTED?
For many companies, QMS document controls, labeling and record keeping are likely to contain more specific requirements when complying with ISO 13485. Part 820 currently includes requirements relates to the methods used in, and the controls for, designing, manufacturing, packaging, labeling, storing, installing and servicing devices. The FDA notes, these requirements are intended to assure that devices are safe and effective and otherwise in compliance with the Federal Food Drug and Cosmetic Act. As the FDA further acknowledges, though the current part 820 applies to many different devices, it does not describe in detail how a manufacturer must design and manufacture a specific device.
With corrective actions, both part 820 and ISO 13485 are in many ways similar. Both call for service records to be evaluated to determine if they meet the definition of compliant. At the risk of oversimplification, both part 820 and ISO 13485, share the following procedures to address corrective and preventive actions:
Collect and analyze data;
Identify non-conformity’s and potential non-conformities;
If action is required, identify the action, and verify if the action identified is effective; and Whether the identified action does not have an adverse effect; and implement and record changes in methods and procedures.
Though the FDA will not be issuing ISO certifications of conformity, we can expect the FDA inspections to continue and to use the requirements of ISO 13485. We can expect that the new FDA inspection model may well be somewhat different in light of the proposed changes. It is not really known at this point as to the expected changes in inspections.
Many knowledgeable commentators have observed that the proposed change does not fundamentally alter the requirements for a quality system that currently exist in FDA Part 820 but allows companies a more streamlined approach. Stephen Grimes, managing partner and principal consultant at Strategic Healthcare Technology Associates LLC. commented: “It makes sense. This is FDA’s efforts to align its QSR with a QMS that has achieved broad international adoption makes sense in the growing global marketplace. With the proposed change, medical device manufac turers will be able to better focus on and adhere to what amounts to one consistent set of requirements in a time when the need for effective quality management has become even more critical.”
One observer representing the indepen dent servicing community, IAMERS President Diana Upton, welcomes the change with a caveat: “the FDA should also keep and indeed strengthen the controls for labeling and packaging in the new regula tion.” Bottom line: It will be interesting to see if this and other suggestions are ultimately adopted after the FDA considers the comments of stakeholders on the proposed rule.
– Robert Kerwin is General Counsel to and Chair of the Best Practices Committee of IAMERS.