Harmonizing ISO 13485 and FDA QSR 21 CFR 820.

The United States FDA made a formal announcement that they will be replacing parts of the existing Quality System Regulation (QSR 21 CFR 820), with the international standard ISO 13485:2016. Currently, this transition is still in the making, and is in the rule stage.  

The hope of the FDA moving to ISO 13485:2016 is to harmonize and modernize the way that quality systems are regulated in the USA. Since the US and international standards vary, it can make record keeping and cost of compliance expensive, but with adoption of the international standard it could help reduce cost and make it easier for US companies to comply internationally.

Benefits of switching to ISO 13485:2016

Switching to an international standard, in this case, ISO 13485:2016 is extremely beneficial to US companies. First, it is more up-to-date than the original QSR. Next it makes working globally a lot easier. There are a lot of similarities between the QSR and ISO 13485, therefore making the transition smooth.

As of now, there are many steps that are still needed before the move is finalized. Although many steps need to be taken, the official announcement does tell us that the government is in fact committed to taking this important step, making ISO 13485:2016 more mandatory for all Medical Device companies. 

Read more about the Benefits of ISO 13485:2016

When will the switch take place?

The FDA’s initiative to use ISO 13485:2016 was set to take place in 2019. The FDA intends to revise its Quality Service regulations for medical devices to better meet the need for requirements that address the international consensus standard for medical device manufacturing. Although the goal was 2019, the FDA faces many logistical challenges in making this switch. They will need to revise multiple agency documents that reference 21 CRF Part 820 and also train FDA investigators how to audit against ISO 13485:2016.

In the meantime, the medical device industry can rely on AAMI TIR102:2019, which is a bi-directional mapping tool that was released on August 30, 2019. 

Purchase a copy of AAMI TIR102:2019 here.

QSR and ISO 13485:2016

The existing QSR is in fact based off many aspects of the original ISO 13485:1996 but has not been updated in over 20 years, and therefore has fallen behind as regulatory expectations have evolved.

ISO 13485:2016 Quality Management Systems for Medical Devices is the International Standard for quality management for the medical device sector. ISO 13485:2016 has harnessed great support from the FDA, and with the adaption to becoming the quality system, it will help harmonize the system to make international trade and business easier. The announcement is important, showing that the standard had gained global recognition. ISO has already become the medical device single audit program for Australia, Brazil, Canada and Japan.


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