Good day Chrisen,
Change over in labelling is always a challenge aspect because of inventory constraints, when to do crossover, existing product from inventory or in the field. There are quite many ways changes to labelling can be done which centre around the Change Order process. If the changes are quite extensive it might be recommended to have a quality plan describe how all the activities will be managed and controlled. As part of this Quality Plan in order to add the warning and information for the hearing aid, you can describe how this would be done in the interim until you have the labelling updated. Of course, FDA does not like over-labelling, but in some circumstances (temporary) this may need to be done, such as in this case with a new regulatory requirement. Myself, I would have a quality plan to address how all the warnings and additional information is being incorporated currently and then linked to a Change Order which is then making the actual change.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 05-Oct-2022 13:01
From: Chrisen Marana
Subject: New FDA Rule on OTC Hearing Aids affecting labeling
Hi,
I work for a hearing aid manufacturer and recently, FDA released a new rule on OTC hearing aids found in this link:
Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids| Federal Register | remove preview |
| | Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids | | The Food and Drug Administration (FDA, we, or the Agency) is establishing a regulatory category for over-the-counter (OTC) hearing aids and making related amendments to update the regulatory framework for hearing aids. Specifically, we define OTC hearing aids and establish applicable... | | View this on Federal Register > |
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I have a question specific to labelling requirements: FDA has issued a new regulation that requires Hearing Aid manufactures to add 3 specific warnings and some additional information to the outer packaging. It applies to all devices launched in US after October 17, 2022 as well as all hearing instruments already on the market from April 14, 2023.
Since this is required for the next 2 weeks, are we able to use an extra label additional to our existing regulatory label in our outer packaging so that we don't have to update all our existing labels for now?
Please let me know if anyone can help.
Thank you!
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Chrisen Marana
Somerset NJ
United States
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