Understanding is critical!


Many of the US Food and Drug Administration (FDA) requirements in the US 21 CFR 820 Quality System Regulation (QSR) for medical devices are similar or virtually identical to the ISO 13485 quality system requirements recognized in Europe.


However, important differences exist between these two sets of requirements, such as:


  • Very detailed requirements in the US QSR for the management of customer complaints, and a specific requirement for documenting investigations that are carried out to determine the ‘root cause’ of a complaint or product problem. The provisions in ISO 13485 related to customer complaints are more general in nature. Companies need to be aware, therefore, of the specific requirements in the QSR.

  • US labeling requirements are also more detailed than those in Europe. For example, US labeling requirements specifically address label integrity, labeling inspection, labeling storage, labeling operations and the need for a control number.

  • The US QSR includes the need to analyze service reports with an appropriate statistical methodology. It is also necessary to have a system in place that allows the recognition of service reports which meet the criteria of adverse events that need to be reported as Medical Device Reports (21 CFR 803).

  • A greater emphasis on process validation by the FDA.


Manufacturers sometimes discover too late that conformity with ISO 13485 is not sufficient to guarantee compliance with FDA requirements. Manufacturers with medical devices on the market in the US must comply specifically with the US QSR.


We will assist personnel, even those who read and/or speak only Italian, to better understand US requirements, by allowing review of these requirements in their native language. This will help avoid misunderstandings that could lead to noncompliance with US requirements.


Please remember, however, that if questions regarding the meaning of a QSR requirement arise, the English edition is the official version and all final conclusions regarding a specific requirement should be based upon the English version.


Contact us for more details.