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the time for a quick review of device reporting that touch the pharma world – especially since FDA just put forth a new draft guidance on Medical Device Reporting:https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm359130.htm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:
- Definition: Manufacturer. See 21CFR803.3 for the full and complex definition of “manufacturer”. For pharma companies, this definition is important because any entity that changes the container, wrapper or labeling is considered a manufacturer. So if a pharma company repackages or includes another company’s device to be marketed with their drug product, the drug company becomes a “manufacturer” for reporting purposes.
- Supplemental Reports. These are follow-up reports and should be submitted within 30 calendar days of the receipt of the new information. Use a MedWatch form or submit electronically.
- Causality: In the above definition “caused or contributed” to a death or serious injury means that the problem “was or may have been attributed to a medical device or that a medical device was or may have been a factor in a death or serious injury” due to device “failure, malfunction, improper or inadequate design, manufacture, labeling or user error.” This is quite different from the causality/relatedness definitions used in the drug world.
- “Reasonably known”. FDA expects the manufacturer to obtain information on the safety problem that is “known or reasonably known”. Information should be gotten by contacting a user facility, importer or reporter and information that can be obtained by analysis, testing or other evaluation of the device.
- Follow-up. The manufacturer should investigate any “written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution” from any source.
FDA states: “You must investigate all complaints of AEs”. Refer to the guidance for further information on due diligence, assisting user facilities in reporting MDRs and other nuances about reporting and follow up.
“MDR follow-up investigations should involve a “good faith effort” to obtain information and should not focus only on the number of attempts to obtain such information.” But then FDA gives a number!
”A “good faith effort” to obtain additional information should include at least one written request for information.”
- Training. “… manufacturers have a responsibility to inform all employees, including marketing, sales, engineering, manufacturing, regulatory, legal, installation, and service personnel, to immediately forward adverse event information to the appropriate person appointed by those entities to submit MDR reports.” The regulatory clock starts when “whenever any employee becomes aware of an adverse event…Employees should be trained…”. Very similar to the drug world.
- Non-reportable MDRs.
- A medical judgment is made by a physician, nurse, risk manager, biomedical engineer or other qualified person that “your device did not cause or contribute to a death or serious injury, or that a malfunction would not be likely to cause or contribute to a death or serious injury if it were to recur.”
- You did not manufacture the device.
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.