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There is no published decision tree that I know of, you have to piece it together from all the definitions. There is alot of good guidance in this thread and on the FDA website.
Here is 2 very valuebale links:
U S Food and Drug Administration Home Page -->DEAD LINK<-- /MedicalDevices/ DeviceRegulationandGuidance / GuidanceDocuments / ucm340518.htm
Medical Device | Longwell & Associates
This just about covers it, but you have to look up and interpret the critical terms:
Each device manufacturer or importer must submit a written report to FDA of any correction or removal of a device initiated by such manufacturer or importer, if one was initiated:
To reduce a risk to health posed by the device; or
To remedy a violation of the Act caused by the device which may present a risk to health, unless the informa-tion has been provided according to 21 CFR 806.10 (f), or the correction or removal action is exempt from the reporting requirements under 21 CFR 806.1(b).
If I had a written flowchart, I'd send it over... Sorry!
Here is 2 very valuebale links:
U S Food and Drug Administration Home Page -->DEAD LINK<-- /MedicalDevices/ DeviceRegulationandGuidance / GuidanceDocuments / ucm340518.htm
Medical Device | Longwell & Associates
This just about covers it, but you have to look up and interpret the critical terms:
Each device manufacturer or importer must submit a written report to FDA of any correction or removal of a device initiated by such manufacturer or importer, if one was initiated:
To reduce a risk to health posed by the device; or
To remedy a violation of the Act caused by the device which may present a risk to health, unless the informa-tion has been provided according to 21 CFR 806.10 (f), or the correction or removal action is exempt from the reporting requirements under 21 CFR 806.1(b).
If I had a written flowchart, I'd send it over... Sorry!
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