Title 21 part 801 section 801.15 (c) 2&3 Languages

If an insert from a German company contains the German language, does this mean that everything in this insert must verbatim in English to comply with this standard?

We are sending out Medical device product inserts with both languages now, I am not sure if all indcations and uses must mirror each other?

Common sense answer would be yes.

Is there any particular reason why would they have to be different?

ISO tired said:

If an insert from a German company contains the German language, does this mean that everything in this insert must verbatim in English to comply with this standard?

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According to the plain language of the regulation, no. According to the section you cite, you are only required to translate information "required by or under the authority of the act". That means that non-required information need not be translated. The reference to words seems to be about required words, such as legally-mandated warnings, etc. According to 21 CFR s 700.3(a), "The termact means the Federal Food, Drug, and Cosmetic Act."

I'm also inclined to say that the substance of this part is that you can't skirt the rules by printing something required under the act in only one of the languages you use, thereby precluding some of the intended users from understanding it adequately.

I would simply ensure that the information in both languages meets the requirements of the act when read alone and without the other language version. I imagine you've already done that. That said, it might be easiest to meet this requirement by translating directly from the original language to the second.

Don't let yourself get stressed out by overzealous people who tell you transliterate every word. I think that suggestion comes from a failure to understand the spirit of the rule.

asfharrison said:

According to the plain language of the regulation, no. According to the section you cite, you are only required to translate information "required by or under the authority of the act". That means that non-required information need not be translated. The reference to words seems to be about required words, such as legally-mandated warnings, etc. According to 21 CFR s 700.3(a), "The termact means the Federal Food, Drug, and Cosmetic Act."

I'm also inclined to say that the substance of this part is that you can't skirt the rules by printing something required under the act in only one of the languages you use, thereby precluding some of the intended users from understanding it adequately.

I would simply ensure that the information in both languages meets the requirements of the act when read alone and without the other language version. I imagine you've already done that. That said, it might be easiest to meet this requirement by translating directly from the original language to the second.

Don't let yourself get stressed out by overzealous people who tell you transliterate every word. I think that suggestion comes from a failure to understand the spirit of the rule.

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Heh. Obviously this discussion needs a representative of the "overzealous" perspective.

The FDA's rules are, concisely put, a mess in regard to languages other than English.

It's been noted in other threads that the FDA remains resistant to the use of internationally standardized symbols, and except for a small set of IVD-label-guidance symbols that some but not all device examiners will accept, generally requires that such symbols must be accompanied by English text descriptions.

Regarding the current question, the FDA's 1989 guidance "Labeling - Regulatory Requirements for Medical Devices", which as far as I can tell remains in effect, states that "(a)ll labeling shall be in English"... thereby omitting the operative limitation to those aspects of the labeling that are required by the Act, to which the previous reply referred.

My overzealous interpretation of this guidance would be that it would be asking for trouble to have label content in German that is not also present, in substantially equal-meaning form, in English. This particularly might be the case for a label that is to be submitted for review as part of a PMN or PMA filing.

The guidance document you're referring to seems to be paraphrasing (and poorly) the regulation itself in this section. I'd be reluctant to accept a guidance document as superseding an established rule. Your reading of the significance of this phrase in the document seems to be overdoing it to me.

I'd also like to point out that this guidance document purports to outlaw puffery and statements of opinion, which the FDA doesn't have the authority to do given that the mere puffery exception to fraud has been well-established through the judiciary for hundreds of years.

Taking a guidance document to overrule established regulation and judicial precedent seems unwise. Rather, I'd read it as containing "explanations and examples of ways that companies can readily comply with labeling requirements."

I think it's especially important to note that the FDA says nearly what I say here in the opening to the document which states that the guidance "does not operate to bind FDA or the public." The also specifically mention that "[a]n alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both."

The regulations supersede the guidance, the guidance doesn't bind the public, and the regulations include explicit provisions as to which labeling information must be translated. Therefore, stricter wording (periphrastic at best) in the guidance should not be read as requiring complete transliteration.

Either way, I agree that the best option is to play it safe. I don't see why you wouldn't just translate the passage. It seemed that the concern here was that the standard required a word-for-word transliteration ("verbatim translation").

Why are you trying to avoid a translation?

asfharrison said:

Taking a guidance document to overrule established regulation and judicial precedent seems unwise.

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As someone that interacts with the FDA regularly to get our 510(k)s through the review process, I would comment to this that the FDA's lawyers do review what's written in guidances, and thence appear qualifications like those you note, but their examiners are not lawyer-supervised and point to non-conformance to guidances (and to their idiosyncratic interpretation of guidances) quite regularly.

Thus, the importance and authority of their guidances depends on what you're trying to get done, and whether you think getting into a dispute with them is an efficient way to get to market.

But then again, I'm overzealous.

Hello all. I´m moving this to the FDA - Medical devices forum, please keep the good discussion.

MIREGMGR said:

[T]heir examiners are not lawyer-supervised and point to non-conformance to guidances (and to their idiosyncratic interpretation of guidances) quite regularly.

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This is the issue, I suppose. I'm talking about dealing with the law, whereas you're talking about dealing with the people. I wish they functioned more similarly than they do.

Thus, the importance and authority of their guidances depends on what you're trying to get done, and whether you think getting into a dispute with them is an efficient way to get to market.

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Fair enough. It just irks me when they require more than they're actually allowed to. It increases everyone's workload and causes unnecessary headaches, and it's just because they don't understand how their job is supposed to work.

But then again, I'm overzealous.

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And I am overly confrontational. Shmeh. Somebody ought to sue them so I don't have to. That would make my day. I'm definitely confident in my reading of the law, but I've never dealt with this issue on the ground before.

I'm still curious as to why you wouldn't be able to satisfy this by just doing a verified translation.

[Edit:] Wouldn't want to do a verified translation.*