Has anybody here from Medical devices industry (not pharma) ever got cited by FDA ( on a 483 letter) for their misleading information on their marketing and promotional material? I want to know what level of RA/QA review and approval is required on these documents, some of our promotional and marketing material don't even have health-related claims on them , so I really don't think RA/QA review and approval is needed on such documents?
HOWEVER:
1. Technically you would be non-compliant. The FDA's Introduction to Medical Device Labeling clearly states "labelling" is anything accompanying product, and "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.", and 21 CFR §820.120 clearly lists control requirements for "labelling".
2. From a QA/RA perspective, it's probably still prudent to exercise some controls, no? You presumably don't want people creating new marketing material, or changing existing ones willy-nilly...
Side Note: In the Introduction to Medical Device Labeling under the "Advertising" heading, it says "According to an appellate court decision: 'Most, if not all advertising, is labeling.'". Any guidance as to what is excluded? Probably safer to just assume "all"...but I'd be interested to know where the exceptions lie.
Edit: For some reason I thought you we talking quality controls in general. I realise now that you are just referring to "RA/QA review and approval". In this case, the only thing required by 21 CFR §820.120 is that labeling is released by "designated individual(s)"...so you could potentially qualify anyone as you deem appropriate.
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