Re: How can I phrase this?
Warnings that are intended for an audiologist or technician are still "labeling" as far as FDA is concerned, no less than warnings that are intended for a patient. FDA regulations do apply in this case.
This is true and is also stated in the guidance documents provided by the FDA.
From: Fred Ridder
Sent: Monday, July 01, 2013 5:20 PM
To: techwr-l -at- lists -dot- techwr-l -dot- com
Subject: RE: How can I phrase this?
All of these rewordings would be fine if the OP were writing a document that the end user of the hearing aid would be reading. But that is *not* the case.
The warning I suggested is audience-neutral and would apply to anyone providing, programming, or using the hearing aid.
WARNING: Damage to the ear will occur when the hearing aid is worn for more than number of hours per day specified. Get the specific number of hours from the prescribing specialist when the hours are not specified.
If you go back to Charlotte's original query, you will find that her company makes the software that an audiologist (or a technician working with one) uses to customize a hearing aid for the end user.
An expert user (hearing care specialist) uses our software to program
One certain feature does in some cases have limitations on use. The client
(hearing aid user) can use the hearing aids for only x hours per day. The
user (hearing care specialist) has to fill in the maximum hours per day in
the Instructions for Use that the client (hearing aid user) receives with
the hearing aids. It is important that the client adheres to the
instructions, as overuse can cause harm.
As you can see Charlotte is working with the manufacturer and providing a warning to the specialist that must accompany the instructions the user will receive. The instructions are covered by FDA regulations.
The warning/instruction that Charlotte needs to write is the one that tells the *audiologist* that they need to inform the client/patient/end user about usage limitations (presumably when the device is configured to provide a large amount of amplification in some particular frequency band). Her user is the middle-man (oops, I'd better make that middle-person) in the process, and the end user is never going to see the message that her user does.
The FDA states that "This labeling is intended to be supplied, or given to and used by patients or their lay caregivers with or without accompanying professional counseling." So your statement that "they need to inform the client/patient/end user about usage limitations" would contradict the FDA requirements.
The end user only sees the Instructions for Use, which the expert is supposed to modify with the usage limitation when applicable. There's little doubt that most or all of the language in the Instructions for Use has been heavily reviewed since it's the end-user document that would have to conform with FDA (and other?) regulations.
The assumption that the documents conform with FDA rules is dangerous. Charlotte's document is intended for a lay person who will program hearing aids. Since the programming will have a direct impact on function of the hearing aid it is covered by the FDA. The programmer is also preparing part of the instructions that go to the hearing aid user and the FDA explicitly includes user instructions in it labeling rules.
Charlotte's task is to find a more emphatic way of instructing the hearing expert (*her* user) what to do to modify/augment it when a warning to the end user (patient/client) is needed.
The specialist might never speak directly to the user. This is the sort of situation that gives rise to the FDA rules that require labeling to be used "without accompanying professional counseling." The warning must always accompany the device and the specialist should not be in a position to "modify/augment" the warning as doing so will expose the manufacturer to legal liability.
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- Re: How can I phrase this?, Jim Jones
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