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Although medical device reporting is a bit out of the domain that many of us in the pharmaceutical world work in, situations sometimes arise where we need to know something about device reporting.  This is true for those of us who have combo drug/device products.  So now would be the time for a quick review of device reporting that touch the pharma world – especially since FDA just put forth a new draft guidance on Medical Device Reporting:https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm359130.htm

This document is aimed at “manufacturers”, including ex-US companies whose devices are cleared for marketing in the US.  It is a Q&A type document but it covers the major points needed for device reporting and references the appropriate US federal regulations.

Here are the major points.  I’ve combined various answers for simplicity.  This is not a complete summary but touches on those areas that drug/pharmaceutical specialists might likely see.  The obligations and requirements for manufacturers are addressed:

Comments: Device reporting is different from drug reporting even though the same MedWatch form is used.  There are significant nuanced (and not so nuanced) differences in definitions, timing (calendar days vs working days) and requirements.  The attempt here is to sensitize those folks who work in the drug world who also happen to have devices (usually in combo products) that they also have device reporting obligations.  Examples include: drug manufacturers who include an injection pen or needles/syringes with their product or spacers with an inhaler.

If you fall into this category, you must take the time to carefully go through the regulations and guidances (there are others) that cover device reporting to FDA.  Note also that worldwide device reporting is not as harmonized as drug reporting and that each region or country has different requirements that the company must be sure to obey.

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