Does introduction of a new brochure require a 510K?



Hello all,

Just wondering if anyone has experience with this. We want to introduce a new brochure for our customers for a medical device. It does not contain any information that was not in our original 510K submitted to FDA but we did not submit any marketing literature with our 510K. Following when to submit a new 510K labelling section there are no new containdications, no change to Indications, warnings or precautions.

Does it require a 510K or a note to file?

Any input appreciated,

Thanks, ElmerF
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Just to clarify. This is a marketing brochure for distributors and hospitals and does not accompany the product.


No 510k needed based on your info above.
Regarding your "note to file" path:
Your doc control SOP and Design Change SOP should drive how you document the no 510k decision and its justification. Someone should be assigned the responsibility of reviewing the impact that the change has on any regulatory requirements and the document's revision history is a good spot to note the 510k decision and justification.


Involved In Discussions
Absolutely agree with regork. A new 510(k) is not necessary if there is not any change in the labeling. A commercial brochures is not considered labeling.


A commercial brochures is not considered labeling.

Ronen is correct...labeling broadly and explicitly includes marketing materials. Anything that communicates a device's intended use and indications, or provides information bearing on the device's safety and effectiveness, is labeling no matter how or when it's communicated to the user or buyer.

However, that's not to say that an existing 510(k) always must be amended.

The key is whether the marketing materials are significantly changed in regard to statements about intended use and indications. Per the new-510(k)-required decision flowchart, any revision or addition to intended use and indications or contraindications requires a new or revised 510(k).


Quite Involved in Discussions
Further, you can refer to the US FDA definitions as below:

Section 201(k) defines 'label' as a:

'display of written, printed, or graphic matter upon the immediate container of any article...'

The term 'immediate container' does not include package liners. Any word, statement, or other information appearing on the immediate container must also appear 'on the outside container or wrapper, if any there be, of the retain package of such article, or is easily legible through the outside container of wrapper.'

Section 201(m) defines 'labeling' as:

'all labels and other written, printed, or graphic matter
(1) upon any article or any of its containers or wrappers, or

(2) accompanying such article' at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce.

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. 'Accompanying' also includes labeling that is brought together with the device after shipment or delivery for shipment in interstate commerce.

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