{"id":27777,"date":"2024-05-24T05:00:00","date_gmt":"2024-05-24T03:00:00","guid":{"rendered":"https:\/\/sii.pl\/blog\/?p=27777"},"modified":"2024-06-21T13:28:52","modified_gmt":"2024-06-21T11:28:52","slug":"iec-62304-software-safety-classes-vs-fda-software-requirements","status":"publish","type":"post","link":"https:\/\/sii.pl\/blog\/en\/iec-62304-software-safety-classes-vs-fda-software-requirements\/","title":{"rendered":"IEC 62304 Software Safety Classes vs. FDA Software Requirements"},"content":{"rendered":"\n

Releasing a medical device (MD) to a single market is difficult, but addressing multiple markets simultaneously adds more complexity. Each market has its regulations that MD manufacturers must comply with. Moreover, regulations constantly develop along with civilization, technological progress, and widespread globalization.<\/p>\n\n\n\n

As a result of this phenomenon, a new FDA guideline for MD Software pre-market submission emerged last year and inspired this article. Before the new release, the FDA distinguished software classes between three “Levels of Concern,” which closely resembled the safety classes defined in IEC 62304. Now, one has to switch to the cryptic-sounding “Documentation Levels<\/strong>” instead.<\/p>\n\n\n\n

Against the backdrop of the above modifications, the article discusses what changes in US regulations an MD software manufacturer faces and how this reflects the EU’s pre-market submission requirements. Delving into the key similarities and differences between the US and EU markets, important issues are highlighted for companies looking to sell their MD software in the two largest medical markets.<\/p>\n\n\n\n

US and EU MD regulations overview<\/strong><\/h2>\n\n\n\n

Both US and EU regulations categorize MD software as a medical device. The regulatory authority for medical devices in the United States is the Food and Drug Administration (FDA), while in the EU, it is the Medical Device Regulation (MDR) or In Vitro Diagnostic Device Regulation (IVDR). Do US and EU regulations share identical rules and classifications? Unfortunately, not. However, there are some similarities worth exploring.<\/p>\n\n\n\n

MD software’s pre-market submission path appears in additional standards and guidelines. The FDA used to describe it in “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” (issued on May 11, 2005), but it has been replaced with guidance for Industry and FDA Staff, “Content of Premarket Submissions for Device Software Functions” (issued on June 14, 2023).<\/p>\n\n\n\n

IEC 62304, a standard describing the MD software life cycle process, is the basic document reflecting EU MDR or IVDR requirements for MD software pre-market activities.<\/p>\n\n\n\n

FDA Level of Concern vs Documentation Level<\/strong><\/h2>\n\n\n\n

FDA used to define three Levels of Concern<\/strong> to determine the amount of documentation required for submission, which were:<\/p>\n\n\n\n

\"Levels<\/a>
Fig. 1 Levels of Concern (Source: FDA Guidance for the Content of Premarket Submission for Software Contained in Medical Devices)<\/figcaption><\/figure>\n\n\n\n

The manufacturer had to choose and stick with one Level of Concern (“LoC\u201d) to proceed. <\/p>\n\n\n\n

The FDA guide provided questions to be asked to assign the appropriate LoC. If a “yes” answer was given to any of the listed major\/moderate level questions, the appropriate level was awarded. A “no\u201d to all questions meant a minor level was assigned<\/p>\n\n\n\n

.<\/p>\n\n\n\n

\"FDA<\/a>
Fig. 2 \u00a0FDA Level of Concern Determining Scheme<\/figcaption><\/figure>\n\n\n\n

Things changed when new FDA guidance has been issued. Instead of the LoC, one goes directly to categorizing required documentation, which is called the Documentation Level<\/strong>. It can be either Basic<\/strong> or Enhanced<\/strong>.<\/p>\n\n\n\n

\"Documentation<\/a>
Fig. 3 Documentation Levels (Source: Content of Premarket Submissions for Device Software Functions)<\/figcaption><\/figure>\n\n\n\n

What happens in the aftermath? FDA-recommended documentation must be adapted as the situation evolves. Below is an outline of these changes. <\/p>\n\n\n\n

This data is presented in simplified terms to highlight the fundamental differences between documentation levels established by the FDA. To check the exact FDA recommendations, please refer to the mentioned guidelines.<\/p>\n\n\n\n

\"FDA<\/a>
Tab. 1 FDA recommended documentation based on Level of Concern (outdated)<\/figcaption><\/figure>\n\n\n\n
\"FDA<\/a>
Tab. 2 FDA recommended documentation based on Documentation Level (valid)<\/figcaption><\/figure>\n\n\n\n

*DoC \u2013 Declaration of Conformity with the FDA-recognized version of IEC 62304 <\/p>\n\n\n\n

What has changed compared to the previous version of the guide? Trying to present these levels together, the same or similar categories of software documentation can be combined:<\/p>\n\n\n\n

\"FDA<\/a>
Tab. 3 FDA recommended documentation from LoC vs. Documentation Level<\/figcaption><\/figure>\n\n\n\n

*DoC \u2013 Declaration of Conformity with the FDA-recognized version of IEC 62304.<\/p>\n\n\n\n

The colors used served as a tool to highlight similarities (green\/orange area) and differences (black area) between one level from LoC and another from the Documentation Level. Diving into this data, the following conclusions can be drawn:<\/p>\n\n\n\n