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:// 


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. 


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.