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< 1 min reading time
As originally asked by Steve Arrants.
Does anyone here document medical devices? Is there a LinkedIn (or other) group that deals with issues around user documentation and training?
Pamela V. Falk
According to the FDA, “instruction books” such as O&M manuals and other user documentation are “labeling,” not “packaging.” The following is directly from the FDA website ([http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/DeviceLabeling/default.htm|leo://plh/http%3A*3*3www%2Efda%2Egov*3MedicalDevices*3DeviceRegulationandGuidance*3Overview*3DeviceLabeling*3default%2Ehtm/PrvQ?_t=tracking_disc]):
“The Federal Food, Drug and Cosmetic Act (FFDCA) is the law under which the FDA takes action against regulated products. Specifically: …
“Section 201(m) defines ‘labeling’ as:
The term ‘accompanying’ is interpreted liberally to mean more than physical association with the product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instruction books, direction sheets, fillers, etc. ‘Accompanying’ also includes labeling that is brought together with the device after shipment or delivery for shipment in interstate commerce.”
You may have to go back to the person or people who told you that your documentation is “packaging” and have them explain how they arrived at that conclusion. And I don’t think it’s unreasonable for them to be able to tell you what those specific methods are that you have to follow. But maybe that’s just me. 🙂
Please forgive me if you’re already familiar with these FDA documents, but I want to make sure I don’t miss anything. Also, perhaps some of this information might give other group members some ideas that might be helpful.
The FDA website page I cited above has links to their general labeling guidance documents for medical devices, including FDA 89-4203, “Labeling – Regulatory Requirements for Medical Devices,” and G91-1, “Device Labeling Guidance.”
I’m not a software writer, so I don’t know offhand what the guidance documents for software are.
Although packaging includes user manuals, packaging is different than labeling. Under “Device Advice: Comprehensive Regulatory Assistance,” chapter 11 covers labeling ([http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/MedicalDeviceQualitySystemsManual/ucm122639.htm|leo://plh/http%3A*3*3www%2Efda%2Egov*3MedicalDevices*3DeviceRegulationandGuidance*3PostmarketRequirements*3QualitySystemsRegulations*3MedicalDeviceQualitySystemsManual*3ucm122639%2Ehtm/fNIs?_t=tracking_disc]) and chapter 13 covers packaging ([http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/MedicalDeviceQualitySystemsManual/ucm122664.htm|leo://plh/http%3A*3*3www%2Efda%2Egov*3MedicalDevices*3DeviceRegulationandGuidance*3PostmarketRequirements*3QualitySystemsRegulations*3MedicalDeviceQualitySystemsManual*3ucm122664%2Ehtm/bQOV?_t=tracking_disc]).
Is any of that what you’re looking for?
If not, the LinkedIn groups I can think of that might be able to steer you in the right direction are Medical Devices and FDA, FDA Compliance Gurus, and FDA Regulated Industries Group. I hope you find what you’re looking for.
Pamela V. Falk
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