Guidance Documents

Guidance documents are both device and Authority Having Jurisdiction specific. For example, the U.S. FDA has a published a guidance document for applying Usability to the design validation of a medical device to be sold within the United States. Health Canada also has guidance documents, and the MDCG has guidance documents released for the E.U.

Unfortunately, there are just too many guidances for use to cover every single one. The ones that may apply to your organization will also vary depending on your device/s, and your markets.

What we can do in this section is address how to find guidance’s so that you can screen them for applicable to your specific operations. Below we will look at ones from the U.S. FDA, Health Canada, and the MDCG.

FDA

Applying Human Factors and Usability Engineering to Medical Devices Guidance for Industry and Food and Drug Administration Staff- FEBRUARY 2016- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-factors-and-usability-engineering-medical-devices

You will note that most guidance documents will contain some variation of the obligatory statement that the FDA uses “Contains Nonbinding Recommendations”. This is because guidance documents are not regulations. They provide additional information and clarification on a specific subject.

There are many guidance documents issued by the FDA alone. Fortunately as the screenshot above shows they also have a searchable database to help you find ones that may apply to your device or operations. The URL for the database is – https://www.fda.gov/regulatory-information/search-fda-guidance-documents

MDCG

For devices within participating member states of the European Union, the Medical Device Coordination Group publishes similar documents. For example:

MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR– https://ec.europa.eu/health/sites/default/files/md_topics-interest/docs/md_mdcg_2019_11_guidance_en.pdf

Not the similar disclaimer language “The document is not a European Commission document, and it cannot be regarded as reflecting the official position of the European Commission. Furthermore, any views expressed in this document are not legally binding, and only the Court of Justice of the European Union can give binding interpretations of Union law.”.

As the screenshot above shows, the MDCG guidances are topic or device specific. If your device is not an implantable device then MDCG 2021-11 Guidance on Implant Card – Device Types probably doesn’t apply. Same for MDCG 2021-4, if your device is not regulated under the IVDR, Regulation (EU) 2017/746 then this guidance may not be much help.

The following URL should bring you to the MDCG website page for their published guidance documents- https://ec.europa.eu/health/md_sector/new_regulations/guidance_en

Health Canada

Health Canada also provides a list of their issued guidance documents. You can also see by the URL color in the screenshot which ones I have most recently visited. These are published at the following URL – https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents.html