The FDA Joins the Rest of the ISO World


The FDA has made a statement about a new proposed rule to “incorporate” ISO 13485 into their quality system regulations for medical devices. They have been working on this for 30+ years.

The current FDA requirements for quality management are contained in their QSR (quality system requirements), contained in 21 CFR 820, have their origin in GMP good manufacturing practice. Some other parts of the CFR relate to GMP, but this is the relevant section for medical devices.

The effective functioning of the requirements in 13485 is about the same as the QSR. It’s always possible to make distinctions or argue superiority, but fundamentally both sets of regulations say and attempt to achieve the same thing – safe and effective devices.

It is also important to mention that the FDA has been active in the MDSAP scheme (Medical Device Single Audit Program). The scheme bases regulatory audits on 13485 and other content that ensures the QSR is met specifically) and which is agreed to be acceptable to other countries. This is an excellent display of cooperation and participation by the FDA and shows commitment to harmonization. Technically, allowing for 13485 is all about harmonization. 13485 is the regulatory standard used throughout Europe, Australia, Canada, Japan, and many other countries. Harmonization and “incorporation” should make life a little easier for medical device manufacturers and the FDA.

It seems a revolutionary change, but in practice, this will likely serve to ensure ongoing consistency with how the FDA has overseen things. Fundamentally the QSR achieves the same goal but says it differently. And by “incorporating” 13485, it does not mean that there won’t be more rules to consider.

Manufacturers will have the opportunity to tidy up their paperwork but are unlikely to change anything significant due to this. It will probably streamline local regulations but will definitely improve the US’s ability to supply devices abroad. Of course, you can argue that the US market is more accessible to overseas organizations, but in this country, we welcome competition, and the consumer market will benefit.

Nothing is going to happen fast. This is only a discussion opportunity for a proposed rule change, but it’s exciting to see the FDA moving towards the driving seat.

There are other challenges to think about too. The standard specifically referenced is ISO 13485:2016. Because of a five-year review period, that standard is currently up for review. That might mean that it moves forward with changes and that the FDA will not adopt that new changed version. A new version would take time for the FDA to review. All of that remains to be seen. 13485 was based upon ISO 9001, which underwent substantive changes when published in 2015. 13485 was being reviewed for update and publication in 2016, starting many years before 9001 published their new version in 2015. 13485 reviewers could not wait for 9001 to be reviewed and published and then review how it might work for 13485 – they had to get on with it. And effectively, that is what the FDA will do. They have to put a stick in the sand with one specific standard and negotiate and organize around it. There is no assurance of what will happen to 13485 in its current review. In the meantime, the FDA will get on with it!

Colin Gray is an ISO and management system consultant on the team at Cavendish Scott. He has been supporting and auditing for management systems in medical device markets and other markets worldwide for 20 years. If you have any questions, you may contact him at

Cavendish Scott is a team of ISO experts, process experts, and best/optimal practice specialists. They help organizations establish sensible, optimized ISO management system solutions and guarantee successful certification. Check out their website at or contact them here

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